Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007

Size: px
Start display at page:

Download "Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007"

Transcription

1 Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 SIEMENS AG Industry Sector Industry Automation D Karlsruhe, Federal Republic of Germany Fax: +49 (721) January 2008 A5E

2 2 A5E

3 Contents Contents 3 Introduction 5 1 Overview of FDA 21 CFR Part 11 Requirements 7 2 Response of SIMATIC WinCC flexible 2007 to 21 CFR Part Technological Solution for Access Protection Technological Solution for Audit Trail Technological Solution for Archiving and Retrieval Technological Solution for Electronic Signatures Evaluation List for SIMATIC WinCC flexible Procedures and Controls for Closed Systems Additional Procedures and Controls for Open Systems Signed Electronic Records Electronic Signatures (General) Electronic Signatures (Non-biometric) Electronic Signatures (Biometric) Controls for Identification Codes and Passwords...23 Abbreviations used 24 A5E

4 4 A5E

5 Introduction Regulation 21 CFR Part 11 "Electronic Records; Electronic Signatures" (ER/ES) of the US regulatory agency Food and Drug Administration (FDA) went into effect on August 20, CFR Part 11: (in short: Part 11) defines the criteria for acceptance by FDA for the use of electronic records and electronic signatures in place of records in paper form and handwritten signatures on paper. In this regard, electronic records and signatures must be as trustworthy, reliable and effective as traditional records. Application of this rule is mandatory for the use of electronic records and signatures. However, Part 11 applies only to records that are required to be maintained according to FDA guidelines (as defined by so-called "predicate rules") or to records that are required to be submitted to the FDA in electronic form. There are various interpretations and recommendations from the FDA as well as from the ISPE and PDA. Beyond the use of electronic records and signatures, traditional paper documents and handwritten signatures, or a combination of both, can still be used. To help its clients, Siemens as a supplier of SIMATIC WinCC flexible, evaluated its systems in regard to these rules. This paper publishes the assessment results of the SIMATIC WinCC flexible 2007 HMI software. SIMATIC WinCC flexible 2007 fully complies with the functional requirements of 21 CFR Part 11. Operation in conformity with the regulations is ensured in conjunction with organizational measures and procedural controls to be established by the client. Siemens recommendations for system architecture, design and configuration will assist the client in achieving compliance. For additional information and assistance see "GMP Engineering Manual: SIMATIC WinCC flexible Guidelines for Implementing Automation Projects in a GMP Environment". The FDA standards are also applied beyond the pharmaceuticals industry in other life sciences (such as the food industry, cosmetics and consumer care, etc.). The requirements of Part 11 are open to interpretation. This document supports the current interpretation of the ISPE CoP GAMP and PDA that is accepted worldwide. If the interpretation of a requirement by a company differs from the requirement specified here, please contact the Competence Center Pharmaceuticals of Siemens AG, Industry Sector, Industry Automation division in Karlsruhe for more information. This document comprises three parts. The first part provides a brief overview of the requirements of Part 11, the second provides the solutions for the main technical requirements from the viewpoint of SIMATIC WinCC flexible 2007 and the third contains a detailed system evaluation according to ISPE / PDA 1. 1 Good Practice and Compliance for Electronic Records and Signatures; Part 2 "Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures"; ISPE and PDA 2001 A5E

6 6 A5E

7 1 Overview of FDA 21 CFR Part 11 Requirements 21 CFR Part 11 takes into account that the risk of falsification, misinterpretation and changes without trace is higher with electronic records and electronic signatures than with conventional paper records and handwritten signatures, or are more difficult to detect. Additional measures are required for this reason. "Electronic Record / Electronic Document" means any combination of text, graphics, data, audio, pictorial or other representation of information in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. 2 "Electronic Signature" means a computer data compilation of any symbol or series of symbols executed, adopted or authorized by an individual to be the legally binding equivalent of the individual s handwritten signature. 1 Requirement Validation Audit Trails Record Retention, Protection, Reproducibility and Retrievability Documentation Controls Access security Electronic Signature Certificate to FDA Description All GMP-relevant automated systems must be validated to ensure precise, reliable and consistent data preparation in accordance with the standards. All operator actions which create, modify or delete an electronic data record must be recorded in a secure, time-stamped, computer-generated audit trail. Systems must have the capability to retain, protect and readily retrieve records throughout the configurable retention period. Systems must be able to reproduce electronic records in both human-readable and electronic form. Controls must exist over access to, revision of, distribution of, and use of documentation for system operation and maintenance. Access to electronic records must be restricted exclusively to authorized and qualified personnel. In open systems, additional security measures must be implemented to ensure this access control (see also 21 CFR Part 11.30). Systems must provide measures to ensure that use of an electronic signature is limited to genuine owners only and that attempted use by others is promptly detected and recorded. Non-biometric systems must employ two distinct identification mechanisms (user ID / password). Both user ID and password must be entered before the signature is made, and at least the password must be entered at each subsequent signing during the same session. Electronic signatures must not be reused or reassigned. The purpose of an electronic signature must be clearly indicated. Finally, systems must include measures to prohibit falsification of electronic signatures using standard tools. Written policies must be in place which hold individuals responsible for actions initiated under their electronic signatures. Written certification must be provided to the FDA Office of Regional Operations that all electronic signatures in use are the legally binding equivalent of traditional handwritten signatures. 2 Good Practice and Compliance for Electronic Records and Signatures; Part 2 "Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures"; ISPE and PDA 2001 A5E

8

9 2 Response of SIMATIC WinCC flexible 2007 to 21 CFR Part 11 The requirements which can be fulfilled by technological solutions can be summarized under four topics: Access security Audit Trail Archiving and retrieval of records Electronic Signature 2.1 Technological Solution for Access Protection The user management configuration is performed centrally on an engineering system for each application and uploaded from there to the respective HMI device (PC or panel). WinCC flexible 2007 supports both local and centralized user management to ensure protection of electronic records. Local user management With local user management, individual users and their assignment to user groups are only known locally. Individual users and their assignment to user groups are defined in the WinCC flexible configuration. Based on user groups, authorizations with authorization levels are defined in the WinCC flexible user administration. Fig. 1 displays the assignment of group rights to user groups A5E

10 The following requirements for access protection are met in this way: Users can only log on to the HMI device with a unique combination of user ID and password. Users can change their own password locally on the HMI device. The following settings with regard to password security are possible: Password with at least one special character Password with at least one digit Minimum password length between 3 and 24 characters Password expiration is supported, and the validity period of a password and the number of generations can be configured. The system can force the user to change the initial password. The user is automatically blocked after three incorrect logon attempts and can only be unlocked by the administrator. The system automatically logs off users after a specified period of time with no activity. Log functions for actions related to access protection in the audit trail, such as logon, manual and automatic logoff, input of wrong user ID or wrong password, user blocked after several attempts to enter incorrect, and password change by user. Fig. 2 displays the configuration on the safety settings of the user administration 10 A5E

11 Centralized user administration Centralized user administration is implemented with the software package SIMATIC Logon 3. SIMATIC Logon is installed on a central computer with an MS Windows operating system (the operating systems supported can be found in the Release Notes of SIMATIC Logon). User management based on MS Windows security mechanisms is set up there. The HMI devices are connected to the computer via Ethernet. Individual users and their assignment to Windows user groups are defined in the Windows user administration. Based on user groups, authorizations with authorization levels are defined in the WinCC flexible user administration. SIMATIC Logon provides the link between the Windows user groups and the WinCC flexible user groups. In the event of the interruption of the network connection, local users can be used to maintain operation. SIMATIC Logon users who are already logged on (central users) remain active until logoff. SIMATIC Logon fulfills the requirements of 21 CFR Part 11 regarding access protection in combination with procedural controls, such as those for "clarifying the responsibility and access permission of the system users". In addition, unauthorized access to the directory structures of the individual system programs should be prevented using the rights allocation of the Windows operating system, thus excluding the chance of unwanted manipulation. If system access is not controlled by individuals who are responsible for the content of the electronic records, the system is defined as "open". If there is an "open path", this path can be secured using standard tools. 3 From SIMATIC Logon V1.4.1 (V1.4 SP1) A5E

12 2.2 Technological Solution for Audit Trail Audit trails are particularly important in situations in which users can create, modify or delete data during normal operation for standardized process documentation in electronic form. WinCC flexible 2007 supports the requirement for audit trail of operator actions which are GMP-relevant by recording such actions in an audit trail log file. The GMP relevant data is defined by the client based on the applicable legal guidelines. We distinguish between changes made during the production or runtime phase of the system from changes made during the offline or configuration phase. Runtime phase The relevant data to be tracked in the audit trail during runtime can be configured on the engineering system. The required information for each record is recorded in a log file. The saved information includes the object name, the old value, new value, date and time stamp, as well as user ID and optionally the reason for the change. Fig. 3: A tag is defined as GMP-relevant so that an audit trail entry is created every time the user changes a value. 12 A5E

13 The audit trail is saved as a CSV file. An integrated algorithm automatically forms a checksum for each record and enables the user to detect manual changes. The audit trail file can be directed to external network resources, which simplifies backup and archiving. Configuration phase Fig. 4: The audit viewer displays the audit trail and confirms with the green signal lamp that the audit trail has not been manipulated. The WinCC flexible 2007 option Change Control enables the tracking of engineering changes in WinCC flexible 2007 projects including archives, alarm displays and graphics, definition of access rights, etc. The project versions are fully reproducible and can be rolled back. The respective project version can also be identified in the audit trail of the runtime. Fig. 5 displays the change log which records the modified configuration in a log file. A5E

14 2.3 Technological Solution for Archiving and Retrieval Process data Registered process data (messages, process values) can be swapped out for long-term archiving as CSV files to local volumes or via the network manually, based on a predefined frequency or process triggered. Depending on the duration of the archiving period, the process data are saved in sequence or circular archives either as CSV files or on a PC platform in ODBC databases (e.g. MS SQL server). You can use all media intended for long-term storage and supported by Windows. Recipe data records (parameters) are managed in an internal format by the system and can be exported and imported in CSV format if desired. In the case of local long-term archiving, the process data can still be displayed on the panel. In the case of long-term archiving over the network, data can be displayed with the help of a spreadsheet or can be imported and displayed by the Premium add-on PM- QUALITY. Audit Trail The audit trail of operator actions during the runtime phase are recorded as an endless archive in the audit trail. These data are transferred from the HMI device to a network PC or local storage medium (CF card) depending on a preset time or the local storage capacity. You can specify the path to the long-term storage location of this audit trail file to guarantee availability of this data. The data can then be saved to other media, such as CD, from this storage location. The audit trail data can be displayed and printed with the WinCC Audit Viewer. 14 A5E

15 2.4 Technological Solution for Electronic Signatures WinCC flexible 2007 supports electronic signatures for user actions. During the configuration phase, administrators can specify which object may require an electronic signature upon change. Users can sign electronically and confirm the intended action by entering their password. This electronic signature is saved in the audit trail along with the user name, the action performed and an additional comment. The comment can be configured as optional or mandatory for each object. Fig. 6: The modification of a tag value is signed electronically, taking into account the mandatory comment. A5E

16 16 A5E

17 3 Evaluation List for SIMATIC WinCC flexible 2007 The questions or requirements of the following checklist used for evaluation of Part 11- Conformity of SIMATIC WinCC flexible 2007 are based on the Good Practice Guide by ISPE and PDA 4. Some of the requirements of 21 CFR Part 11 have to be met through the implementation of corresponding procedural controls by the client. The specifications of 21 CFR Part 11 always relate to the client specific application, which was implemented with WinCC flexible This means the solutions then specified are valid only in conjunction with specific procedural controls and organizational measures. 3.1 Procedures and Controls for Closed Systems If system access is controlled by individuals who are responsible for the content of the electronic records, then the system is defined as closed and must be assessed against the requirements of this section. Paragraph/ Item 11.10(a) Item (a) Item 2 Questions / Requirements Is the system validated? Is it possible to detect invalid or altered records? Comments The client is responsible for the validation of the applications/system. The validation should follow an established system life cycle (SLC) methodology, e.g. as described in GAMP 4 5. SIMATIC WinCC flexible 2007 has been developed according to the Siemens Quality Management system (ISO 9001:2000 certified). The validation of the application can be supported by Siemens during projects upon request. This is done by creating an audit trail of operator actions. The Audit Trail Viewer displays available data records. The data to be logged in the audit trail are labeled during configuration by the "GMP-relevant" setting. A checksum is calculated for each data record and integrated in the audit trail. This process will help detect any manipulations to the audit trail. The required information for each record is recorded in a log file. The saved information includes the object name, the old value, new value, date and time stamp, as well as user ID and optionally the reason for the change. Changes within the configuration of WinCC flexible can be tracked with the option Change Control. 4 Good Practice and Compliance for Electronic Records and Signatures; Part 2 "Complying with 21 CFR Part 11, Electronic Records and Electronic Signatures"; ISPE and PDA GAMP 4 Guide for Validation of Automated Systems, ISPE 2001 A5E

18 Paragraph/ Item 11.10(b) Item (b) Item (c) 11.10(d) 11.10(e) Item (e) Item (e) Item (e) Item 4 Questions / Requirements Is the system capable of producing accurate and complete copies of electronic records on paper? Is the system capable of producing accurate and complete copies of records in electronic form for inspection, review and copying by the FDA? Are the records readily retrievable throughout their retention period? Is system access limited to authorized individuals? Is there a secure, computergenerated, time-stamped audit trail that records the date and time of operator entries and actions that create, modify, or delete electronic records? If a change is made to electronic data, is previously recorded information still available? (or is it, for example, obscured by the change?) Is the audit trail of an electronic record retrievable throughout the entire retention period of the record? Is the audit trail available for review and copying by the FDA? Comments The process data (process values, alarms and messages) can be transferred to a network resource and are then available to other applications for printing. The audit trail can be displayed and printed with the WinCC Audit Viewer. Both process data and audit trails are generated as CSV files and can be saved to a network resource. The system uses resources available over a network to save the data over time. From there records can be archived in a readable format, e.g. on CD or DVD. We assume that these devices and formats will also be readable in the future. Clients should also specify retention periods and define procedures for archiving, backup and retrieval of electronic records. All options for user management from Windows are provided by implementing centralized user administration with SIMATIC Logon. With local user management, only authorized individuals can log on to the system using their user ID and password. In this case, the local runtime security settings are applied (see section 2, Technological Solution for Access Protection). Client should ensure that only individuals who have a legitimate reason to use the system should be granted physical access to the system (e. g. HMI devices, engineering system). Because this requirement is virtually the same as 11.10(g), it is generally interpreted to refer to both physical access and logical access. The audit trail is secure within the system and cannot be changed by a user. Changes during production can be traced back by the system itself and contain information with time stamp, user ID, old and new value and comment. The old and new value are recorded in the audit trail when changes are made to parameter values via the user interface. Process data which are electronically recorded by the system cannot be modified by the user via the user interface. The audit trail can be made available during the entire retention period. (see (c)) Availability is ensured by logging in a separate CSV file. 18 A5E

19 Paragraph/ Item 11.10(f) 11.10(g) 11.10(h) 11.10(i) 11.10(j) 11.10(k) Item (k) Item 2 Questions / Requirements If the sequence of system steps or events is important, is this also taken into account by the system (e.g. as would be the case in a process control system)? Does the system ensure that only authorized individuals can use the system, electronically sign records, access the operation or the computer system input or output devices, alter a record, or perform other operations? If it is a requirement of the system that input data or instructions can only come from certain input devices (e.g. terminals), does the system check the validity of the source of any data or instructions received? (Comment: This applies where data or instructions can come from more than one device, and the system must therefore verify the integrity of its source, such as a network of weigh scales, or remote, radio-controlled terminals.) Is there documented training, including on-the-job training for system users, developers, IT support staff? Is there a written policy that holds individuals fully accountable and responsible for actions initiated under their electronic signatures? Is the distribution of, access to, and use of system operation and maintenance documentation controlled? Is there a formal control procedure for revisions to system documentation that maintains a time-sequenced audit trail for those changes made by the pharmaceutical company? Comments A specific sequence of operator actions can be realized by configuring the application accordingly. WinCC flexible 2007 provides local user management with user groups, authorizations and users. It thereby regulates the administration of system access as well as individual authorizations. The use of an electronic signature requires password input. Centralized user administration can be implemented with SIMATIC Logon (see (d)). The WinCC flexible devices can be configured so that special input of data / commands can only be performed from a dedicated workstation or from a group of dedicated workstations. All other workstations then have only read-access rights at the most. Siemens offers either standard training courses or training related to client projects, which must be planned and executed separately. The client is responsible for initiating and planning these trainings. Clients are responsible for providing procedural controls. Clients are responsible for providing procedural controls. Clients are responsible for providing procedural controls. A5E

20 3.2 Additional Procedures and Controls for Open Systems If system access is NOT controlled by individuals who are responsible for the content of the electronic records, the system is defined as "open" and must in addition be assessed against the requirements of this section. We recommend using WinCC flexible 2007 as a closed system. Paragraph/ Item Item Item 2 Questions / Requirements Is data encrypted? Are digital signatures used? Comments WinCC flexible was designed for operation in closed systems. For operation in open systems, the "open path" of the data transfer has to be protected by means of commercially available standard tools. WinCC flexible was designed for operation in closed systems. For operation in open systems, the "open path" of the data transfer has to be protected by means of commercially available standard tools. 3.3 Signed Electronic Records See also Section 2 (System Solutions for Electronic Signatures) Paragraph/ Item Questions / Requirements Comments Item Item 2 Do signed electronic records contain the following information? Printed name of the signer Date and time of signing Meaning of the signature (such as approval, review, responsibility) Is the information mentioned above shown on displayed and printed copies of the electronic record? Are signatures linked to their respective electronic records to ensure that they cannot be cut, copied, or otherwise transferred to other records for the purpose of falsification? Signed electronic records also include the following information: a) User ID of the signer b) Date and time of signing c) Including the meaning The above-mentioned information is part of the audit trail and can be printed and displayed. The electronic signature is a component of the signed record within the audit trail. It is protected against change by the integrated checksum. 20 A5E

21 3.4 Electronic Signatures (General) Paragraph/ Item (a) Item (a) Item (b) Questions / Requirements Are electronic signatures unique to an individual? Are electronic signatures ever reused by, or reassigned to, anyone else? Is the identity of an individual verified before an electronic signature is allocated? Comments The electronic signature uses the user's user ID and password. The uniqueness of the user ID is ensured by the MS Windows security system when SIMATIC Logon is used. It is not possible to define two users with the same user ID within a workgroup / domain. If local user management is used, the uniqueness of the user ID and the combination of user ID and password are ensured with WinCC flexible. In addition, the client must ensure the uniqueness of the electronic signature to an individual. The client has to ensure and is responsible that a user ID is assigned to one individual only. This remains the responsibility of the client. He must provide organizational measures Electronic Signatures (Non-biometric) Paragraph/ Item (a)(1)(i) (a)(1)(ii) (a)(1)(iii) (a)(2) Questions / Requirements Is the signature made up of at least two components, such as an ID code and password, or an ID card and password? When several signatures are made during a continuous session, is the password entered for each signature? (Comment: both components must be executed for the first signature in a session.) If signatures are not entered in a continuous session, are both components of the electronic signature executed for each signature? Are non-biometric signatures only used by their real owners? Comments SIMATIC Logon or WinCC flexible identify the individual with two distinct components: User ID and password. When signing is performed, the user ID of the logged on user is always given by the system. The password must be entered for each signing. The user ID is always given by the system and only the password component must be entered. The client is responsible for providing procedural controls that prevent passwords from becoming known. A5E

22 Paragraph/ Item (a)(3) Questions / Requirements Would an attempt to falsify an electronic signature require the collaboration of at least two individuals? Comments It is not possible to falsify an electronic signature during signing. The administrator cannot misuse the signature, although he configures the user ID and initial password, because the user is forced to change his password at the first logon. Unauthorized use of user IDs / passwords (failed logon attempts) is detected immediately and recorded. An unauthorized change by the administrator once a record is saved would result in a change to its checksum, and the falsification would be detected. In addition, the client should provide procedural controls that prevent the disclosure of passwords Electronic Signatures (Biometric) Paragraph/ Item (b) Questions / Requirements Can biometric electronic signatures be used only by their real owner? Comments Biometric signature procedures are currently not supported by WinCC flexible. 22 A5E

23 3.5 Controls for Identification Codes and Passwords If tokens, cards or other devices bearing or generating identification code or password information are used on this system for electronic signatures, the system must be assessed against the requirements in this section. Paragraph/ Item (a) (b) Item (b) Item (b) Item (c) (d) Item (d) Item 2 Questions / Requirements Are controls in place to maintain the uniqueness of each identification code and password combination which ensure that no other individual can have the same combination of identification code and password? Are procedures in place to ensure that the validity of identification codes is checked regularly? Do passwords periodically expire and need to be checked? Is there a procedure for canceling identification codes and passwords if a person leaves the company or is transferred? Is there a procedure for electronically changing an identification code or password if it is potentially compromised or lost? Is there a procedure for detecting attempts at unauthorized use and for informing the security system? Is there a procedure for reporting repeated or serious attempts at unauthorized use to the administrator? Comments See (a). Clients are responsible for creating procedural controls. Clients are responsible for creating procedural controls. A password expires after a specified number of days and cannot be reused for a specified number of generations. User accounts can be disabled using SIMATIC Logon for central user administration in conjunction with the MS Windows security system. If the local user management of WinCC flexible is used, user access cannot be disabled or locked. A user group can, however, be created without active authorizations and such an employee can be assigned to this group. The employee data would therefore be maintained historically in the system, but the employee would no longer be in a position to perform unauthorized actions in the system. Clients are responsible for creating procedural controls. Users can change their password at any time if there is any suspicion of a breach of security. Passwords can be reset by administrators at any time if they are "forgotten". A user ID can be "disabled" by organizational measures, such as that described under (b) item 3. Failed access attempts are recorded in the audit trail and can be identified and traced there. The user account is locked after a specified number of unauthorized attempts. In addition, clients are responsible for providing appropriate organizational measures. Clients are responsible for providing appropriate organizational measures. A5E

24 Abbreviations used CF: Compact Flash CFR: Code of Federal Regulations CoP: Community of Practice CSV: Comma Separated Values FDA: Food and Drug Administration GAMP: Good Automated Manufacturing Practice GMP: Good Manufacturing Practice HMI: Human Machine Interface ID: Identification ISO: International Organization for Standardization ISPE: International Society for Pharmaceutical Engineering IT: Information Technology ODBC: Open Database Connectivity PDA: Parenteral Drug Association (now "International Association for Pharmaceutical Science and Technology") SQL: Structured Query Language 24 A5E

Compliance Response Edition 07/2009. SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures. simatic wincc DOKUMENTATION

Compliance Response Edition 07/2009. SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures. simatic wincc DOKUMENTATION Compliance Response Edition 07/2009 SIMATIC WinCC V7.0 Compliance Response Electronic Records / Electronic Signatures simatic wincc DOKUMENTATION Compliance Response Electronic Records / Electronic Signatures

More information

SIMATIC SIMATIC PCS 7 V8.0. Electronic Records / Electronic Signatures. Compliance Response. Answers for industry.

SIMATIC SIMATIC PCS 7 V8.0. Electronic Records / Electronic Signatures. Compliance Response. Answers for industry. SIMATIC SIMATIC PCS 7 V8.0 Electronic Records / Electronic Signatures Compliance Response Edition 09/2012 Answers for industry. Compliance Response Electronic Records / Electronic Signatures for SIMATIC

More information

Compliance Response SIMATIC SIMATIC PCS 7 V8.1. Electronic Records / Electronic Signatures (ERES) Edition 03/2015. Answers for industry.

Compliance Response SIMATIC SIMATIC PCS 7 V8.1. Electronic Records / Electronic Signatures (ERES) Edition 03/2015. Answers for industry. SIMATIC SIMATIC PCS 7 V8.1 Electronic Records / Electronic Signatures (ERES) Compliance Response Edition 03/2015 Answers for industry. Compliance Response Electronic Records / Electronic Signatures (ERES)

More information

Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries

Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries White Paper No 01 I December 2010 Implementation of 21 CFR Part 11 in the epmotion Software Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device

More information

21 CFR Part 11 White Paper

21 CFR Part 11 White Paper 21 CFR Part 11 White Paper Version V8.00 SR1 ProLeiT AG Einsteinstrasse 8, D-91074 Herzogenaurach, Germany Phone: +49 (0) 9132 777-0 Fax: +49 (0) 9132 777-150 E-Mail: info@proleit.com Internet: http://www.proleit.com

More information

Implementation of 21CFR11 Features in Micromeritics Software Software ID

Implementation of 21CFR11 Features in Micromeritics Software Software ID Implementation of 21CFR11 Features in Micromeritics Software Software ID PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A General Provisions Sec. 11.1 Scope. 11.2 Implementation. 11.3 Definitions.

More information

Full Compliance Contents

Full Compliance Contents Full Compliance for and EU Annex 11 With the regulation support of Contents 1. Introduction 2 2. The regulations 2 3. FDA 3 Subpart B Electronic records 3 Subpart C Electronic Signatures 9 4. EU GMP Annex

More information

FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER

FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER FILEHOLD DOCUMENT MANAGEMENT SYSTEM 21 CFR PART 11 COMPLIANCE WHITE PAPER Copyright 2012 FileHold Systems Inc. All rights reserved. For further information about this manual or other FileHold Systems products,

More information

The Impact of 21 CFR Part 11 on Product Development

The Impact of 21 CFR Part 11 on Product Development The Impact of 21 CFR Part 11 on Product Development Product development has become an increasingly critical factor in highly-regulated life sciences industries. Biotechnology, medical device, and pharmaceutical

More information

DeltaV Capabilities for Electronic Records Management

DeltaV Capabilities for Electronic Records Management January 2013 Page 1 DeltaV Capabilities for Electronic Records Management This paper describes DeltaV s integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications

More information

Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System. White Paper. By Frank Tontala

Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System. White Paper. By Frank Tontala Tools to Aid in 21 CFR Part 11 Compliance with EZChrom Elite Chromatography Data System White Paper By Frank Tontala Agilent Technologies Software & Informatics Life Sciences & Chemical Analysis Group

More information

Empower TM 2 Software

Empower TM 2 Software Empower TM 2 Software 21 CFR PART 11 COMPLIANCE ASSESSMENT Revision A, December, 2005 1 of 14 Waters Corporation Note: Information presented in this document assumes that the appropriate Empower 2 System

More information

Agilent UV-Visible ChemStation with Security Pack

Agilent UV-Visible ChemStation with Security Pack Agilent UV-Visible ChemStation with Security Pack Compliance with 21 CFR Part 11 Introduction Part 11 in Title 21 of the Code of Federal Regulations includes the US Federal guidelines for storing and protecting

More information

Agilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA)

Agilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA) Agilent MicroLab Software with Spectroscopy Configuration Manager and Spectroscopy Database Administrator (SCM/SDA) Compliance with 21 CFR Part 11 Introduction Part 11 in Title 21 of the Code of Federal

More information

Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures

Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Self-Assessment of eresearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures Subpart A General Provisions Sec. 11.1 Scope. (a) The regulations in this part set forth the criteria

More information

Oracle WebCenter Content

Oracle WebCenter Content Oracle WebCenter Content 21 CFR Part 11 Certification Kim Hutchings US Data Management Phone: 888-231-0816 Email: khutchings@usdatamanagement.com Introduction In May 2011, US Data Management (USDM) was

More information

Compliance Matrix for 21 CFR Part 11: Electronic Records

Compliance Matrix for 21 CFR Part 11: Electronic Records Compliance Matrix for 21 CFR Part 11: Electronic Records Philip E. Plantz, PhD, Applications Manager David Kremer, Senior Software Engineer Application Note SL-AN-27 Revision A Provided By: Microtrac,

More information

DeltaV Capabilities for Electronic Records Management

DeltaV Capabilities for Electronic Records Management September 2004 Page 1 An integrated solution for meeting FDA 21CFR Part 11 requirements in process automation applications using a configurable off-the-shelf (COTS) solution Emerson Process Management.

More information

21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES 21.11.2013. 21 CFR Part 11 Compliance PLA 2.1

21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES 21.11.2013. 21 CFR Part 11 Compliance PLA 2.1 21 CFR PART 11 ELECTRONIC RECORDS, ELECTRONIC SIGNATURES Compliance of PLA 2.1 21.11.2013 21 CFR Part 11 Compliance PLA 2.1 SEC. 11.2 IMPLEMENTATION. (a) For records required to be maintained but not submitted

More information

Implement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system.

Implement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system. 21 CRF 11 Electronic Records and Signatures Implement best practices by using FileMaker Pro 7 as the backbone of your 21 CFR 11 compliant system. By Todd Duell What does Title 21 of the Code of Federal

More information

FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry

FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry FDA 21 CFR Part 11 Electronic records and signatures solutions for the Life Sciences Industry The Rule 21 CFR Part 11 Handwritten signature means the scripted name or legal mark of an individual handwritten

More information

Assessment of Vaisala Veriteq vlog Validation System Compliance to 21 CFR Part 11 Requirements

Assessment of Vaisala Veriteq vlog Validation System Compliance to 21 CFR Part 11 Requirements / WHITE PAPER Assessment of Vaisala Veriteq vlog Validation System Compliance to 21 CFR Part 11 Requirements The 21 CFR Part 11 rule states that the FDA view is that the risks of falsification, misinterpretation,

More information

ScreenMaster RVG200 Paperless recorder FDA-approved record keeping. Measurement made easy

ScreenMaster RVG200 Paperless recorder FDA-approved record keeping. Measurement made easy Information INF13/147 EN ScreenMaster RVG200 Paperless recorder FDA-approved record keeping Measurement made easy Guidance on the use of the RVG200 paperless recorder for electronic record keeping in FDA-approved

More information

21 CFR Part 11 Compliance Using STATISTICA

21 CFR Part 11 Compliance Using STATISTICA 21 CFR Part 11 Compliance Using STATISTICA Last Updated: April 2003 This document was updated to reflect the FDA s latest guidance (released February, 2003) and the withdrawal of previous guidance.! STATSOFT

More information

InfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures

InfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures InfoCenter Suite and the FDA s 21 CFR part 11 Electronic Records; Electronic Signatures Overview One of the most popular applications of InfoCenter Suite is to help FDA regulated companies comply with

More information

InfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements

InfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements InfinityQS SPC Quality System & FDA s 21 CFR Part 11 Requirements www.infinityqs.com Copyright InfinityQS International Table of Contents Overview... FDA s 21 CFR Part 11 Requirements... PART 11 ELECTRONIC

More information

21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0

21 CFR Part 11 Deployment Guide for Wonderware System Platform 3.1, InTouch 10.1 and Historian 9.0 Deployment Guide 21 CFR Part 11 Deployment Guide for Authors: Invensys Operations Management and TSD (Total System Design, an Optimation Company) Table of Contents by Section 1 Before you Begin...............................................................................................

More information

21 CFR Part 11 Electronic Records & Signatures

21 CFR Part 11 Electronic Records & Signatures Gap Analysis - Checklist 21 CFR Part 11 Electronic Records & Signatures his document is a proposal and starting point only. he type and extent of documentation depends on the process environment. he proposed

More information

Spectroscopy Configuration Manager (SCM) Software. 21 CFR Part 11 Compliance Booklet

Spectroscopy Configuration Manager (SCM) Software. 21 CFR Part 11 Compliance Booklet Spectroscopy Configuration Manager (SCM) Software 21 CFR Part 11 Compliance Booklet Notices Agilent Technologies, Inc. 2015 No part of this manual may be reproduced in any form or by any means (including

More information

21 CFR Part 11 Implementation Spectrum ES

21 CFR Part 11 Implementation Spectrum ES 21 CFR Part 11 Implementation Spectrum ES INFRARED SPECTROSCOPY T E C H N I C A L N O T E Introduction Compliance with 21 CFR Part 11 is mandatory for pharmaceutical companies and their suppliers to sell

More information

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E.

Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. Implementing Title 21 CFR Part 11 (Electronic Records ; Electronic Signatures) in Manufacturing Presented by: Steve Malyszko, P.E. President & CEO Agenda Introduction Who is Malisko Engineering? Title

More information

White paper inforouter in the Life Sciences Industry: 21 CFR Part 11 Compliance

White paper inforouter in the Life Sciences Industry: 21 CFR Part 11 Compliance White paper inforouter in the Life Sciences Industry: 21 CFR Part 11 Compliance Overview of 21 CFR Part 11 The final version of the 21 CFR Part 11 regulation released by the FDA in 1997 provides a framework

More information

Checklist / 21 CFR part 11 Compliance for WHT32-Software

Checklist / 21 CFR part 11 Compliance for WHT32-Software The following document informs about the CFR 21 Part 11 compliance status of the PTZ 32 Software Package which is used to drive and control an automated Tablet Testing System Type WHT 3ME and a Multiple

More information

SolidWorks Enterprise PDM and FDA 21CFR Part 11

SolidWorks Enterprise PDM and FDA 21CFR Part 11 T E C H N I C A L P A P E R SolidWorks Enterprise PDM and FDA 21CFR Part 11 This Technical Paper discusses the technical solutions provided by SolidWorks Enterprise PDM to address the FDA 21 CFR Part 11

More information

Enabling SharePoint for 21 CFR Part 11 Compliance - Electronic Signature Use Case

Enabling SharePoint for 21 CFR Part 11 Compliance - Electronic Signature Use Case Enabling SharePoint for 21 CFR Part 11 Compliance - Electronic Signature Use Case Sudeep Nambiar Technical Strategist www.linkedin.com/in/sudeepnambiar/ Thanks to our Sponsors! Platinum: Gold: Silver:

More information

FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997)

FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) www.qadata.co.za Introduction FDA Title 21 CFR Part 11:Electronic Records; Electronic Signatures; Final Rule (1997) INITIAL REGULATION RELEASED High profile audit findings Industry complaints to wasting

More information

Implementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11

Implementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11 Implementing CitectSCADA to meet the requirements of FDA 21 CFR Part 11 Version 2.0 July 2008 FDA 21 CFR Part 11 READY Reversed out on solid background colour Background In 1991, members of the pharmaceutical

More information

Intland s Medical Template

Intland s Medical Template Intland s Medical Template Traceability Browser Risk Management & FMEA Medical Wiki Supports compliance with IEC 62304, FDA Title 21 CFR Part 11, ISO 14971, IEC 60601 and more INTLAND codebeamer ALM is

More information

A ChemoMetec A/S White Paper September 2013

A ChemoMetec A/S White Paper September 2013 NucleoCounter NC-3000, NucleoView NC-3000 Software and Code of Federal Regulation 21 Part 11; Electronic Records, Electronic Signatures (21 CFR Part 11) A ChemoMetec A/S White Paper September 2013 ChemoMetec

More information

Thermal Analysis. http://www.fda.gov. Subpart A General Provisions 11.1 Scope. 11.2 Implementation. 11.3 Definitions.

Thermal Analysis. http://www.fda.gov. Subpart A General Provisions 11.1 Scope. 11.2 Implementation. 11.3 Definitions. Thermal Analysis 21 CFR 11 Compliance 21 CFR Part 11 Electronic Records; Electronic Signatures General concept The U.S. Federal Food and Drug Administration (FDA) has issued regulations that provide criteria

More information

POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM

POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM W H I T E P A P E R POLICY ISSUES IN E-COMMERCE APPLICATIONS: ELECTRONIC RECORD AND SIGNATURE COMPLIANCE FDA 21 CFR 11 ALPHATRUST PRONTO ENTERPRISE PLATFORM This white paper is written for senior executives

More information

21 CFR Part 11 Checklist

21 CFR Part 11 Checklist 21 CFR Part 11 Checklist GUIDE NOTOCORD - 113 Chemin de Ronde - 78290 Croissy-sur-Seine www.notocord.com my.notocord.com support@notocord.com +33 (0)1 34 80 00 00 1. Preliminary information 1.1. Purpose

More information

VISIONsecurity Software: 21 CFR Part 11 Compliance

VISIONsecurity Software: 21 CFR Part 11 Compliance VISIONsecurity Software: 21 CFR Part 11 Compliance The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete.

More information

Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories

Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories Technical Note 43106 Key Words Compliance, Electronic Records, 21 CFR Part 11 Goal

More information

AutoSave. Achieving Part 11 Compliance. A White Paper

AutoSave. Achieving Part 11 Compliance. A White Paper AutoSave Achieving Part 11 Compliance A White Paper Synopsis This whitepaper provides information related to FDA regulation 21 CFR Part 11 (Part 11) for organizations considering MDT software solutions.

More information

Compliance in the BioPharma Industry. White Paper v1.0

Compliance in the BioPharma Industry. White Paper v1.0 in the BioPharma Industry White Paper v1.0 July 2005 I. Introduction...3 II. Overview of Regulations...3 III. Overview of Validation...4 a. Validation...4 b. Security s Part Within Validation...6 IV. Introduction

More information

Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11)

Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11) Meeting the FDA s Requirements for Electronic Records and Electronic Signatures (21 CFR Part 11) Executive Summary...3 Background...4 Internet Growth in the Pharmaceutical Industries...4 The Need for Security...4

More information

FOR THE SERVING DOCUMENT NUMBER: FRS-001 DATE ISSUED: 11/12/08 REVISION: 0 PREPARED BY DANIEL WATERMAN VALIDATION MANAGER

FOR THE SERVING DOCUMENT NUMBER: FRS-001 DATE ISSUED: 11/12/08 REVISION: 0 PREPARED BY DANIEL WATERMAN VALIDATION MANAGER FUNCTIONAL REQUIREMENTS SPECIFICATION FOR THE EXAMPLE VALIDATION SPREADSHEET SERVING OFNI SYSTEMS RALEIGH, NORTH CAROLINA DOCUMENT NUMBER: FRS-001 DATE ISSUED: 11/12/08 REVISION: 0 PREPARED BY DANIEL WATERMAN

More information

epblue GxP oftware manual Software version 20.4.1 075 900.874

epblue GxP oftware manual Software version 20.4.1 075 900.874 ee ab. pblue n. ig. p. manual GxP oftware manual epblue GxP Software manual Software version 20.4.1 075 900.874 Copyright 2012 Eppendorf AG, Hamburg. No part of this publication may be reproduced without

More information

For technical assistance, please contact: Thermo Nicolet Corporation 5225 Verona Road Madison WI 53711-4495

For technical assistance, please contact: Thermo Nicolet Corporation 5225 Verona Road Madison WI 53711-4495 The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Thermo Nicolet Corporation shall not be liable

More information

TIBCO Spotfire and S+ Product Family

TIBCO Spotfire and S+ Product Family TIBCO Spotfire and S+ Product Family Compliance with 21 CFR Part 11, GxP and Related Software Validation Issues The Code of Federal Regulations Title 21 Part 11 is a significant regulatory requirement

More information

rsdm and 21 CFR Part 11

rsdm and 21 CFR Part 11 rsdm and 21 CFR Part 11 Meeting the 21 CFR Part 11 Burden without Overburdening The right solutions for smaller biopharma. Nothing more. Nothing less. Prepared by: Ken VanLuvanee www.virtualregulatorysolutions.com

More information

Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories

Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories Thermo Scientific Qtegra Intelligent Scientific Data Solution (ISDS) Software for 21 CFR Part 11 Compliant Laboratories Technical Note 43106 Key Words Compliance, Electronic Records, 21 CFR Part 11 Goal

More information

Supplement to the Guidance for Electronic Data Capture in Clinical Trials

Supplement to the Guidance for Electronic Data Capture in Clinical Trials Supplement to the Guidance for Electronic Data Capture in Clinical Trials January 10, 2012 Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Note: The original language of this

More information

Software Manual Part IV: FDA 21 CFR part 11. Version 2.20

Software Manual Part IV: FDA 21 CFR part 11. Version 2.20 Software Manual Part IV: FDA 21 CFR part 11 Version 2.20 OPTIMA Software Manual Part IV: FDA 21 CFR part 11 BMG LABTECH This manual was designed to guide OPTIMA users through the software features related

More information

Why LabX balance fully supports FDA 21CFR Part 11

Why LabX balance fully supports FDA 21CFR Part 11 Why LabX balance fully supports FDA 21CFR Part 11 This article is intended to answer some frequently asked questions concerning the support of FDA 21 CFR Part 11 within LabX pro balance, the METTLER TOLEDO

More information

Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements

Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements Electronic Records and Signatures: Compliance with Title 21 CFR Part 11 Requirements Version 4.5. June 2015 Contents 1 Introduction... 3 2 Definitions (21 CFR Part 11: para 11.3)... 3 3 Administrative

More information

How are tags and messages archived in WinCC flexible? WinCC flexible. FAQ May 2011. Service & Support. Answers for industry.

How are tags and messages archived in WinCC flexible? WinCC flexible. FAQ May 2011. Service & Support. Answers for industry. How are tags and messages archived in WinCC flexible? WinCC flexible FAQ May 2011 Service & Support Answers for industry. Question This entry is from the Service&Support portal of Siemens AG, Sector Industry,

More information

Manual 074 Electronic Records and Electronic Signatures 1. Purpose

Manual 074 Electronic Records and Electronic Signatures 1. Purpose 1. Purpose The purpose of this document is to provide an interpretation of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures (ER/ES) and to provide guidance for acceptable practices in the

More information

Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide

Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide WHITE PAPER SDS Software v2.x Enterprise Edition Considerations for validating SDS Software v2.x Enterprise Edition for the 7900HT Fast Real-Time PCR System per the GAMP 5 guide This white paper describes

More information

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1

Nova Southeastern University Standard Operating Procedure for GCP. Title: Electronic Source Documents for Clinical Research Study Version # 1 Nova Southeastern University Standard Operating Procedure for GCP Title: Electronic Source Documents for Clinical Research Study Version # 1 SOP Number: OCR-RDM-006 Effective Date: August 2013 Page 1 of

More information

Comfort Panels, Runtime Advanced - Advanced Configuration Options SIMATIC HMI

Comfort Panels, Runtime Advanced - Advanced Configuration Options SIMATIC HMI Comfort Panels, Runtime Advanced - Advanced Configuration Options SIMATIC HMI WinCC V12 Comfort Panels, Runtime Advanced - Advanced Configuration Options Getting Started 1 Welcome Create decentralized

More information

SIMATIC. SIMATIC Logon. User management and electronic signatures. Hardware and Software Requirements. Scope of delivery 3.

SIMATIC. SIMATIC Logon. User management and electronic signatures. Hardware and Software Requirements. Scope of delivery 3. SIMATIC SIMATIC SIMATIC User management and electronic signatures 1 Hardware and Software Requirements 2 Scope of delivery 3 Installation 4 5 Configuration Manual 08/2008 A5E00496669-05 Legal information

More information

Using the Thermo Scientific Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with 21 CFR Part 11. Compliance Guide

Using the Thermo Scientific Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with 21 CFR Part 11. Compliance Guide Using the Thermo Scientific Dionex Chromeleon 7 Chromatography Data System (CDS) to Comply with 21 CFR Part 11 Compliance Guide Table of Contents Introduction... 3 PART 11 ELECTRONIC RECORDS; ELECTRONIC

More information

LabChip GX/GXII with LabChip GxP Software

LabChip GX/GXII with LabChip GxP Software Regulatory Compliance LabChip GX/GXII with LabChip GxP Software Supporting Regulatory Compliance Caliper LabChip GX/GXII suite of instruments provides automated electrophoresis to analyze quality, size,

More information

Access Control and Audit Trail Software

Access Control and Audit Trail Software Varian, Inc. 2700 Mitchell Drive Walnut Creek, CA 94598-1675/USA Access Control and Audit Trail Software Operation Manual Varian, Inc. 2002 03-914941-00:3 Table of Contents Introduction... 1 Access Control

More information

This interpretation of the revised Annex

This interpretation of the revised Annex Reprinted from PHARMACEUTICAL ENGINEERING The Official Magazine of ISPE July/August 2011, Vol. 31 No. 4 www.ispe.org Copyright ISPE 2011 The ISPE GAMP Community of Practice (COP) provides its interpretation

More information

Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11)

Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) Eclipsys Sunrise Clinical Manager Enterprise Electronic Medical Record (SCM) and Title 21 Code of Federal Regulations Part 11 (21CFR11) The title 21 code of federal regulations part 11 deals with an institutions

More information

System Configuration Management and Version Control in an FDA Regulated Environment

System Configuration Management and Version Control in an FDA Regulated Environment Presented at the World Batch Forum North American Conference Woodcliff Lake, NJ April 13-16, 2003 107 S. Southgate Drive Chandler, Arizona 85226-3222 480-893-8803 Fax 480-893-7775 E-mail: info@wbf.org

More information

Using Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11

Using Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11 Technical Note 54 Using Chromeleon Chromatography Management Software to Comply with 21 CFR Part 11 The Electronic Records and Signatures Rule 1, known as 21 CFR Part 11, was established by the U.S. Food

More information

Electronic Document and Record Compliance for the Life Sciences

Electronic Document and Record Compliance for the Life Sciences Electronic Document and Record Compliance for the Life Sciences Kiran Thakrar, SoluSoft Inc. SoluSoft, Inc. 300 Willow Street South North Andover, MA 01845 Website: www.solu-soft.com Email: solusoftsales@solu-soft.com

More information

Waters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance

Waters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance THE ROLE OF WATERS EMPOWER 2 SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower 2 Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of

More information

Data Management PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th -11 th, 2007

Data Management PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th -11 th, 2007 Data Management PACT Workshop: Design & Operation of GMP Cell Therapy Facilities April 10 th -11 th, 2007 Data Management Discuss Database Development Design Process Tips Data Normalization Reporting Ideas

More information

Guidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps

Guidance for Industry. 21 CFR Part 11; Electronic. Records; Electronic Signatures. Time Stamps Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Time Stamps Draft Guidance This guidance document is being distributed for comment purposes only. Comments and suggestions

More information

AuthentiMax Software for GloMax -Multi+

AuthentiMax Software for GloMax -Multi+ TECHNICAL MANUAL AuthentiMax Software for GloMax -Multi+ Instruc ons for use of Product E8946. TM403 Revised 9/13 AuthentiMax Software for GloMax -Multi+ All technical literature is available on the Internet

More information

Life sciences solutions compliant with FDA 21 CFR Part 11

Life sciences solutions compliant with FDA 21 CFR Part 11 Life sciences solutions compliant with FDA 21 CFR Part 11 System 800xA facilitates regulatory compliance As part of ABB s strategy we have invested considerably in the development of advanced solutions

More information

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Computerized Systems Used in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance

More information

REGULATIONS COMPLIANCE ASSESSMENT

REGULATIONS COMPLIANCE ASSESSMENT ALIX is free software: you can redistribute it and/or modify it under the terms of the GNU General Public License as published by the Free Software Foundation. REGULATIONS COMPLIANCE ASSESSMENT BUSINESS

More information

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management

U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management U.S. FDA Title 21 CFR Part 11 Compliance Assessment of SAP Records Management Disclaimer These materials are subject to change without notice. SAP AG s compliance analysis with respect to SAP software

More information

Using Electronic Signatures

Using Electronic Signatures Using Electronic Signatures Copyright Proprietary Notice The manual and software contain confidential information which represents trade secrets of GE Fanuc International, Inc. and/or its suppliers, and

More information

PREPARED BY: AUDIT PROGRAM Author: Lance M. Turcato. APPROVED BY: Logical Security Operating Systems - Generic. Audit Date:

PREPARED BY: AUDIT PROGRAM Author: Lance M. Turcato. APPROVED BY: Logical Security Operating Systems - Generic. Audit Date: A SYSTEMS UNDERSTANDING A 1.0 Organization Objective: To ensure that the audit team has a clear understanding of the delineation of responsibilities for system administration and maintenance. A 1.1 Determine

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Source Data in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for

More information

SIMATIC STEP 7 V5.4. GMP-Engineering Manual. Guidelines for Implementing. Automation Projects in a GMP. Environment

SIMATIC STEP 7 V5.4. GMP-Engineering Manual. Guidelines for Implementing. Automation Projects in a GMP. Environment s SIMATIC STEP 7 V5.4 GMP-Engineering Manual Guidelines for Implementing Automation Projects in a GMP Environment Introduction Contents Prerequisites for Configuring Automated Systems in a GMP Environment

More information

Sympatec GmbH System-Partikel-Technik WINDOX 4. Electronic Records/ Electronic Signatures Compliance Assessment Worksheet for 21 CFR Part 11

Sympatec GmbH System-Partikel-Technik WINDOX 4. Electronic Records/ Electronic Signatures Compliance Assessment Worksheet for 21 CFR Part 11 Sympatec GmbH System-Partikel-Technik WINDOX 4 Electronic Records/ Electronic Signatures Compliance Worksheet for 21 CFR Part 11 Note Complete or partial duplication of the present documentation and

More information

Achieving PCI COMPLIANCE with the 2020 Audit & Control Suite. www.lepide.com/2020-suite/

Achieving PCI COMPLIANCE with the 2020 Audit & Control Suite. www.lepide.com/2020-suite/ Achieving PCI COMPLIANCE with the 2020 Audit & Control Suite 7. Restrict access to cardholder data by business need to know PCI Article (PCI DSS 3) Report Mapping How we help 7.1 Limit access to system

More information

FDA 21 CFR Part 11 Features

FDA 21 CFR Part 11 Features FDA 21 CFR Part 11 Features Introduction... 2 Remarks... 3 General... 3 Electronic Records (Event Logger, Alarms, Reports)... 3 Electronic Signatures (Security System)... 3 Security System... 4 Security

More information

U.S. FDA TITLE 21 CFR PART 11 COMPLIANCE ASSESSMENT OF SAP LEARNING SOLUTION

U.S. FDA TITLE 21 CFR PART 11 COMPLIANCE ASSESSMENT OF SAP LEARNING SOLUTION U.S. FDA TITLE 21 CFR PART 11 COMPLIANCE ASSESSMENT OF SAP LEARNING SOLUTION Disclaimer These materials are subject to change without notice. SAP AG s compliance analysis with respect to SAP software performance

More information

Waters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance

Waters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance THE ROLE OF WATERS EMPOWER SOFTWARE IN ASSISTING IN 21 CFR PART 11 COMPLIANCE Waters Empower Software Seamlessly Manages Regulated Data to Aid in 21 CFR Part 11 Compliance Summary The objective of this

More information

Progress zenon projects to FDA 21 CFR Part 11 compliance

Progress zenon projects to FDA 21 CFR Part 11 compliance Progress zenon projects to FDA 21 CFR Part 11 compliance History Date Comment 18.08.2010 Robert Harrison, original author 2 Contents History... 2 Contents... 3 1. Introduction... 4 2. Objective... 4 3.

More information

SIMATIC. SIMATIC WinCC (TIA Portal) V13 Guidelines for Implementing Automation Projects in a GMP Environment. GMP Engineering Manual

SIMATIC. SIMATIC WinCC (TIA Portal) V13 Guidelines for Implementing Automation Projects in a GMP Environment. GMP Engineering Manual SIMATIC SIMATIC WinCC (TIA Portal) V13 Guidelines for Implementing Automation Projects in a GMP Environment GMP Engineering Manual Edition 09/2014 Answers for industry. Introduction Configuring in a GMP

More information

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS

Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS Guidance for Industry COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS U.S. Department of Health and Human Services Food and Drug Administration Center for Biologic Evaluation and Research (CBER) Center for

More information

SIMATIC PCS 7 V6.1. GMP - Engineering Manual. Guidelines for implementing automation projects in a GMP environment

SIMATIC PCS 7 V6.1. GMP - Engineering Manual. Guidelines for implementing automation projects in a GMP environment s SIMATIC PCS 7 V6.1 Guidelines for implementing automation projects in a GMP environment Introduction Contents Prerequisites for Configuring Automated Systems in a GMP Environment Requirements for Automated

More information

WinCC Runtime Professional Readme SIMATIC HMI. WinCC V11 SP1. Readme WinCC Runtime Professional. Special considerations for Windows 7.

WinCC Runtime Professional Readme SIMATIC HMI. WinCC V11 SP1. Readme WinCC Runtime Professional. Special considerations for Windows 7. WinCC Runtime Professional Readme SIMATIC HMI WinCC V11 SP1 Special considerations for Windows 7 1 Installation 2 Runtime 3 Options 4 HMI devices 5 Readme WinCC Runtime Professional System Manual Online

More information

Agilent ChemStation Security Pack for AD, GC, LC, CE, LC-MSD, and CE-MSD. User s Guide

Agilent ChemStation Security Pack for AD, GC, LC, CE, LC-MSD, and CE-MSD. User s Guide Agilent ChemStation Security Pack for AD, GC, LC, CE, LC-MSD, and CE-MSD User s Guide A Notices Agilent Technologies, Inc. 2004 No part of this manual may be reproduced in any form or by any means (including

More information

testo Saveris 21CFR Part 11 Software Instruction manual

testo Saveris 21CFR Part 11 Software Instruction manual testo Saveris 21CFR Part 11 Software Instruction manual 2 1 Contents 1 Contents 1 Contents... 3 2 Specifications... 4 2.1. Intended purpose... 4 2.2. 21 CFR Part 11 and terminology used... 5 3 First steps...

More information

FINAL DoIT 04.01.2013- v.8 APPLICATION SECURITY PROCEDURE

FINAL DoIT 04.01.2013- v.8 APPLICATION SECURITY PROCEDURE Purpose: This procedure identifies what is required to ensure the development of a secure application. Procedure: The five basic areas covered by this document include: Standards for Privacy and Security

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Source Data in Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft

More information

Analyst 1.6 Software. Laboratory Director s Guide

Analyst 1.6 Software. Laboratory Director s Guide Analyst 1.6 Software Laboratory Director s Guide Release Date: August 2011 This document is provided to customers who have purchased AB SCIEX equipment to use in the operation of such AB SCIEX equipment.

More information

INFORMATION TECHNOLOGY CONTROLS

INFORMATION TECHNOLOGY CONTROLS CHAPTER 14 INFORMATION TECHNOLOGY CONTROLS SCOPE This chapter addresses requirements common to all financial accounting systems and is not limited to the statewide financial accounting system, ENCOMPASS,

More information

DANGER indicates that death or severe personal injury will result if proper precautions are not taken.

DANGER indicates that death or severe personal injury will result if proper precautions are not taken. Multi-User Systems 1 ArchiveServer 2 SIMATIC HMI WinCC V7.0 SP1 File Server 3 WinCC ServiceMode 4 Redundant Systems 5 System Manual Print of the Online Help 11/2008 Legal information Warning notice system

More information