21 CFR Part 11 White Paper

Size: px
Start display at page:

Download "21 CFR Part 11 White Paper"

Transcription

1 21 CFR Part 11 White Paper Version V8.00 SR1

2 ProLeiT AG Einsteinstrasse 8, D Herzogenaurach, Germany Phone: +49 (0) Fax: +49 (0) Internet: Hotline V8.00 SR1 R02, Edition: 27. April 2010 PiT_V801_21CFR-Part11_en.doc No responsibility can be assumed for the details contained in this manual; changes can be made at any time. The software described in this document is subject to the license conditions. Designations for hardware and software mentioned in this manual are registered trademarks of hardware and software products. Note We thank Maas & Peither GMP-Verlag for their support in the creation of this document. 2

3 Table of contents Table of contents 1 Introduction Fundamentals The 21 CFR Part 11 regulation Term definitions Electronic batch records Recordings always required by FDA CFR Part Compliance Policy Guide 7132a Additional FDA requirement from 21 CFR Part Validation Audit trail Access protection Storage Documentation Recordings and data pools managed by Evaluation of with regard to the requirements of 21 CFR Part Application-specific specifications Evaluation table

4 Introduction 1 Introduction FDA regulation 21 CFR Part 11: Electronic Records; Electronic Signature The 21 CFR Part 11 regulation of the US authority FDA (Food and Drug Administration) took effect on August 20, The regulation describes which requirements the FDA places on the use of electronic recordings and signatures rather than those in paper form. These must be equivalent to the traditional recording in paper form. It is also possible to use a combination of electronic recordings and recordings in paper form. Operational areas for provides a uniform system platform for automation solutions in the process engineering industry. It covers the complete area of the automation and information technology from the field level through to the enterprise resource planning level. Since 1999, the systems have been used increasingly in the pharmaceutical industry so that they have been and will be continually adapted to the growing requirements demanded by the European and US authorities. Content of this document This document describes how the requirements of 21 CFR Part 11 can be satisfied by the system and the appropriate organizational measures to ensure that the system user can operate the system in conformance with the regulation. 4

5 Fundamentals The 21 CFR Part 11 regulation 2 Fundamentals 2.1 The 21 CFR Part 11 regulation The 21 Code of Federal Regulations (CFR), Part 11 title contains the legal regulations of the FDA (US authority for supervising food and medicinal products) concerning the use of electronic recordings and electronic signatures. Definitions for the electronic recording and electronic signature terms are contained in sections 11.3 (6) and (7) of the regulation. Purpose of the regulation Part 11 was originally issued on July 21, 1992 as preannouncement of a draft law. The purpose of this initiative was to accelerate the approval process for medicinal products. However, the other consequences, namely the acceptance of both information and signatures for the approval in electronic form, were apparent immediately. After six years of cooperation between various authorities and the pharmaceutical industry, the final regulation took effect on August 20, Content of the regulation Part 11 specifies the legal prerequisites under which electronic recordings and signatures are accepted as being equivalent to recordings on paper and handwritten signatures. Part 11 assumes that the danger of manipulation and non-traceable changes to electronic recordings and signatures is greater than for paper form and additional measures must be adopted. The term electronic recording In this document, electronic recording refers to data that is relevant for the manufacturing regulations for medicinal products (21 CFR Part 210 and Part 211) and which the system records (e.g. temperature changes), creates (e.g. signaling of a limit value violation) or manages (e.g. material stocks). 5

6 Fundamentals Term definitions 2.2 Term definitions The following table contains the term definitions in accordance with the Part 11. Terms definition from the regulations (Original) 1 Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. 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. Comment by ProLeiT can be operated as closed system in which intervention by the responsible person (e.g. the plant operator) can be fully controlled. If the system is used together with other systems on a single computer or networks are connected physically, the plant operating company must evaluate the complete system. Examples within the system include batch recipes, batch log, measured value recordings, messages, etc. Requires no further explanation This is the replacement for the hand-written signature. Currently, user identification and password are in most common use. Biometric procedures are being used increasingly. 1 Source: Gesetze der USA, Maas & Peither GMP-Verlag, ISBN:

7 Fundamentals Term definitions Terms definition from the regulations (Original) 1 Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. Biometrics means a method of verifying an individual s identity based on measurement of the individual s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. Comment by ProLeiT A user must be able to be uniquely assigned to an electronic signature, where the authorization, e.g. the password, must be stored encrypted. The user identification and password must be entered for the first signature during a session. Further signatures within this session should be performed with at least the input of one of these components. The purpose of the signature must be specified clearly and unambiguously. If required, can integrate external systems for the biometric acquisition. 7

8 Electronic batch records Recordings always required by FDA 3 Electronic batch records 3.1 Recordings always required by FDA CFR Part 211 Plant operating companies subject to the FDA regulations must manage various recordings for the manufactured products. 21 CFR Part 211, Current Good Manufacturing Practice (cgmp) for Finished Pharmaceuticals, Subpart J defines what these are. These explicitly required recordings and reports contain the following: Log of the device use and cleaning Recordings about raw materials, packaging and labeling Central production and controller recordings Batch production and controller recordings Laboratory reports Sales reports Complaints For some of these recordings, such as the batch recordings, large parts of the required information are recorded or created by the computer system. The requirements placed on the type of information are not changed by Part Compliance Policy Guide 7132a.15 In addition to those recordings defined precisely in the cgmp, there is another group of recordings that must be managed similarly. Part 211 Subpart J refers to manufacturing and controller instructions. For a manually-operated process, these instructions exist in paper form as work instructions. In the case of a computer-controlled automated process, these instructions exist as source code for the application programming. The implicit relationship between source code and recordings was established in 1987 by the FDA as the Compliance Policy Guide 7132a.15 that states: Relationship: Source code and recordings We regard source code and its supporting documentation for application programs used in drug process control to be part of master production and control records, within the meaning of 21 CFR Parts 210 and

9 Electronic batch records Additional FDA requirement from 21 CFR Part Additional FDA requirement from 21 CFR Part Validation All GMP-relevant automated systems must be validated Audit trail All quality-relevant operations must be recorded in a reliable automaticallycreated audit trail Access protection The access to electronic recordings must be restricted to a qualified and authorized group of persons Storage The systems must be able to archive, protect and, on request, make available the electronic recording Documentation For the documentation created during the validation, quality procedures must exist for the storage, access, distribution and use. 9

10 Electronic batch records Recordings and data pools managed by 3.3 Recordings and data pools managed by The following table lists the recordings and data pools acquired by. Recordings for system parts System configuration General operator interventions Batch management Batch operator interventions Batch log Process history Process log Example - Definition of the users and their access rights - Sequence logic - Alarm configuration - Control method - Graphical representations - Audit trail - Setpoint and value changes - Failure acknowledgements - Definition of process equipment and process cells - Phase definitions - Recipes - Interventions in the batch operation (start, hold, cancel) - Changes in formulas, parameters and execution sequences - Phase messages and operator responses - Batch reports - Configuration of the recording of trends and views - Curve definitions - Curve data 10

11 Evaluation of with regard to the requirements of 21 CFR Part 11 Application-specific specifications 4 Evaluation of with regard to the requirements of 21 CFR Part Application-specific specifications In the Compliance Policy Guide , FDA has prepared regulations for the implementation of 21 CFR Part 11 in which they allow the own inspectors large freedom with regard to regulatory measures. The FDA does not issue any certificates for products such as, neither is any other independent authority permitted to do this. The plant operating company must always satisfy the specifications of 21 CFR Part 11 for the specific application. Whether the prerequisites are satisfied is decided for each specific case. 4.2 Evaluation table The following table contains the requirements of 21 CFR Part 11 and the evaluation of ProLeiT AG how the requirements are satisfied by the system and/or by regulatory measures of the plant operating company. Wording of the regulation (Original) a Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Comment concerning The plant operating company is responsible for validating the system This should be done using recognized regulations and procedures, e.g. life cycle model (e.g. Gamp4/5). The system was developed in accordance with the ProLeiT AG quality management system that is certified as ISO 9001:2000 conform. The system supports the validation of the application. The system does not support any subsequent changes to the electronic recordings. Recordings - Audit trail: For operator interventions, an audit trail is created in the system for all relevant changes. The system access protection prevents any changes being made to this. - Measured values: The measured values are recorded as binary file in the access-protected database. - Engineering: Changes in the Configuration Client are recorded in their own audit trail. The system access protection prevents any changes being made to this. 2 Source: Gesetze der USA, Maas & Peither GMP-Verlag, ISBN:

12 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) 2 Comment concerning b The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records c Protection of records to enable their accurate and ready retrieval throughout the records retention period d Limiting system access to authorized individuals e Use of secure, computergenerated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying f Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. Paper form Standard logs are available for the output of the recorded data. The audit trail exists as a system-protected csv file that can be printed. The complete configuration in the Configuration Client can be imported and printed using Excel. Electronic form All applications also provide the information as a file. (csv, pdf, xls) Recordings are protected during their storage by their method of storage and by the access protection of the system. They can be archived in readable form on storage medium. This is ensured by the system-internal user management. All parameterization tools are integrated in the user management. An audit trail is maintained for operator interventions and automatic execution sequences of the system. The data is logged centrally on the server with timestamp (taking account of daylight saving), user name, operator station, executing program and description of the operator action, possibly with old and new value. The audit trail is available in csv format on the central server. It is protected by the user authorization of the operating system. The configured objects can be used as basis for the definition of the locking functions. A specific execution sequence can be forced in the S88-conform batch system. User interventions for confirmation or verification can also be configured here. Note The logged-on user is always entered in the audit trail (csv files). The verifier is noted in the electronic signatures table. This will remain so, up to and including V

13 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) g Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand h Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction i Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks j The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification k Use of appropriate controls over systems documentation including: 1. Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. 2. Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation a Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: Comment concerning This is ensured by the user management. Operator actions are logged in a uniform manner in the audit trail with details of the process equipment, user, timestamp and the description of the action, possibly with old and new value. ProLeiT can provide only support here. This includes product seminars offered in the ProLeiT training center. As support for the seminars, detailed product manuals exist and hotline support is available. The plant operating company must provide an organizational solution for the maintenance and correct use of the electronic signature. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. 13

14 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) 2 1. The printed name of the signer; 2. The date and time when the signature was executed; and 3. The meaning (such as review, approval, responsibility, or authorship) associated with the signature b The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout) Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means a Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else b Before an organization establishes, assigns, certifies, or otherwise sanctions an individual s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. Comment concerning The name of the signing person from the user management must be able to be determined unambiguously and in plain language. All signatures are stored with date and time. The system automatically takes account of daylight saving. The significance can be configured in the application that requires an electronic signature. (For example, for an execution sequence using appropriate operator requests) All information in the system can be displayed or printed appropriately. The system can display and print the groups, users, rights and the parameterized assignments known to the system. Printing notes As of V8.20, the ReDoc function will be reactivated for the user management. This allows the user management to be printed. Electronic signatures, including a unique link to the reference document (e.g. batch, order, object, message, etc.), are entered in a systemprotected database table. This is guaranteed using system-internal unique user IDs. A user ID can occur just once. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. 14

15 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) c Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. 1. The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer s handwritten signature a Electronic signatures that are not based upon biometrics shall: Comment concerning The plant operating company is responsible for the organization and the provision of appropriate quality procedures. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. The plant operating company is responsible for the organization and the provision of appropriate quality procedures. 1. Employ at least two distinct identification components such as an identification code and password. 1.i. When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. 1.ii When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. The signature consists of a user ID and the associated password. Signatures always consist of a user identification and the associated password. The user logged on to a session will be entered as default user for the electronic signature and only needs to enter his/her password. Alternatively, a user who is not logged on can sign by entering his/her user identification and password. Signatures always consist of a user identification and the associated password. The user logged on to a session will be entered as default user for the electronic signature and only needs to enter his/her password. Alternatively, a user who is not logged on can sign by entering his/her user identification and password. 15

16 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) 2 2. Be used only by their genuine owners 3. Be administered and executed to ensure that attempted use of an individual s electronic signature by anyone other than ist genuine owner requires collaboration of two or more individuals b Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: a Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password b Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). Comment concerning This can only be guaranteed and monitored by the plant operating company. The electronic signatures cannot be forged because the entries in the database are protected using a checksum. To prevent misuse, passwords can only be changed by the user him/herself or reset by an authorized person, i.e. this person must have been assigned the appropriate rights. This requires an appropriate assignment into responsibility areas by the plant operating company. Failed attempts to sign a document will be logged. Although does not offer any electronic signatures based on biometric characteristics in the system, if required, external systems for the biometric acquisition can be integrated. This is guaranteed using system-internal unique user IDs. A user ID can occur just once. Users can be required to change their password after a parameterized time. To prevent password repetition, the number of passwords to be remembered and which cannot be reused can be parameterized. 16

17 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table Wording of the regulation (Original) c Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls d Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management e Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. Comment concerning This can only be guaranteed and monitored by the plant operating company. Failed authorizations will be logged. This function must be activated from the configuration. If the number of failed logons exceeds the parameterized number of failed logons before the block time is activated, a block time will be active for all subsequent logon attempts. This can only be guaranteed and monitored by the plant operating company. 17

18 Evaluation of with regard to the requirements of 21 CFR Part 11 Evaluation table 18

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007

Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 Declaration of Conformity 21 CFR Part 11 SIMATIC WinCC flexible 2007 SIEMENS AG Industry Sector Industry Automation D-76181 Karlsruhe, Federal Republic of Germany E-mail: pharma.aud@siemens.com Fax: +49

More information

How To Control A Record System

How To Control A Record System 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

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

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

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

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

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

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 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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

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

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

Software. For the 21 CFR Part 11 Environment. The Science and Technology of Small Particles

Software. For the 21 CFR Part 11 Environment. The Science and Technology of Small Particles Software For the 21 CFR Part 11 Environment The Science and Technology of Small Particles 21 CFR Part 11 Solution confirm Software The Code of Federal Regulations Title 21, Part 11, was implemented by

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

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

Achieving 21 CFR Part 11 Compliance with Appian

Achieving 21 CFR Part 11 Compliance with Appian Achieving 21 CFR Part 11 Compliance with Appian Executive Summary Software performance in the life sciences industry has extremely high standards. The FDA and other regulatory bodies require software used

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

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

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

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

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

Guidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Maintenance of Electronic Records

Guidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Maintenance of Electronic Records Draft Guidance for Industry -- Not For Implementation Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Maintenance of Electronic Records Draft Guidance This guidance document

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

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

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

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

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

21 CFR Part 11 LIMS Requirements Electronic signatures and records

21 CFR Part 11 LIMS Requirements Electronic signatures and records 21 CFR Part 11 LIMS Requirements Electronic signatures and records Compiled by Perry W. Burton. Version 1.4, 8 Sept 2014 Table of contents 1. Purpose of this document 1 1.1 Notes to version 1.4 1 1.2 About

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

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

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

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

Quality Manual # QS001.3. MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality

Quality Manual # QS001.3. MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality # QS001.3 MD Logistics, Inc. (Signed copy available upon request) Prepared by Robert Grange, Director Quality Date Review indicates that qualified persons from operational areas have reviewed the content

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

Guidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Electronic Copies of Electronic Records

Guidance for Industry. 21 CFR Part 11; Electronic Records; Electronic Signatures. Electronic Copies of Electronic Records Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Electronic Copies of Electronic Records Draft Guidance This guidance document is being distributed for comment purposes only.

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

THE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE

THE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE THE ROLE OF WATERS NUGENESIS SDMS IN 21 CFR PART 11 COMPLIANCE The objective of this article is to discuss the 21 CFR Part 11 compliance utility of the Waters NuGenesis Scientific Data Management System

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

Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application

Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research

More information

Risk-Based Approach to 21 CFR Part 11

Risk-Based Approach to 21 CFR Part 11 3109 W. Dr. Martin Luther King, Jr. Blvd., Suite 250 Tampa, FL 33607 USA Tel: 813/960-2105 Fax: 813/264-2816 www.ispe.org Risk-Based Approach to 21 CFR Part 11 The 21 CFR Part 11 regulation is a comprehensive

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

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

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

Excel Spreadsheets and FDA Device Regulations

Excel Spreadsheets and FDA Device Regulations Excel Spreadsheets and FDA Device Regulations Dan O Leary CBA, CQA, CQE, CRE, SSBB, CIRM President Ombu Enterprises, LLC Dan@OmbuEnterprises.com www.ombuenterprises.com 603-209-0600 1 Outline Overview

More information

A unique biometrics based identifier, such as a fingerprint, voice print, or a retinal scan; or

A unique biometrics based identifier, such as a fingerprint, voice print, or a retinal scan; or SBA Procedural Notice TO: All SBA Employees CONTROL NO.: 5000-1323 SUBJECT: Acceptance of Electronic Signatures in the 7(a) and 504 Loan Program EFFECTIVE: 10/21/14 The purpose of this Notice is to inform

More information

January 30, 2014 Mortgagee Letter 2014-03

January 30, 2014 Mortgagee Letter 2014-03 U.S. DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT WASHINGTON, DC 20410-8000 ASSISTANT SECRETARY FOR HOUSING- FEDERAL HOUSING COMMISSIONER January 30, 2014 Mortgagee Letter 2014-03 To: All FHA-Approved Mortgagees

More information

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014

Welcome Computer System Validation Training Delivered to FDA. ISPE Boston Area Chapter February 20, 2014 Welcome Computer System Validation Training Delivered to FDA ISPE Boston Area Chapter February 20, 2014 1 Background Training Conducted on April 24, 2012 Food & Drug Administration Division of Manufacturing

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Pharmaceuticals Brussels, SANCO/C8/AM/sl/ares(2010)1064599 EudraLex The Rules Governing Medicinal Products

More information

Good Electronic Records Management (GERM) Using IBM Rational ClearCase and IBM Rational ClearQuest

Good Electronic Records Management (GERM) Using IBM Rational ClearCase and IBM Rational ClearQuest A technical discussion of Good Electronic Records Management using Rational software from IBM 04/03 Good Electronic Records Management (GERM) Using IBM Rational ClearCase and IBM Rational ClearQuest Matthew

More information

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software

More information

Using Digital Signatures in SAP QM to Meet Regulatory Requirements

Using Digital Signatures in SAP QM to Meet Regulatory Requirements By Carl Dunlap, Cohesion, Inc. Using Digital Signatures in SAP QM This article was provided exclusively to SearchSAP.com by SAPtips, an online, subscriptionbased publication dedicated to SAP implementation

More information

Sponsor Site Questionnaire FAQs Regarding Maestro Care

Sponsor Site Questionnaire FAQs Regarding Maestro Care Sponsor Site Questionnaire FAQs Regarding Maestro Care Data Security and Validation 1. Are the electronic source documents or computer systems specific to the site and/or developed by the site? a. Developed

More information

Department of Veterans Affairs VA DIRECTIVE 6510 VA IDENTITY AND ACCESS MANAGEMENT

Department of Veterans Affairs VA DIRECTIVE 6510 VA IDENTITY AND ACCESS MANAGEMENT Department of Veterans Affairs VA DIRECTIVE 6510 Washington, DC 20420 Transmittal Sheet VA IDENTITY AND ACCESS MANAGEMENT 1. REASON FOR ISSUE: This Directive defines the policy and responsibilities to

More information

Neutralus Certification Practices Statement

Neutralus Certification Practices Statement Neutralus Certification Practices Statement Version 2.8 April, 2013 INDEX INDEX...1 1.0 INTRODUCTION...3 1.1 Overview...3 1.2 Policy Identification...3 1.3 Community & Applicability...3 1.4 Contact Details...3

More information

Alfresco CoSign. A White Paper from Zaizi Limited. March 2013

Alfresco CoSign. A White Paper from Zaizi Limited. March 2013 A White Paper from Zaizi Limited March 2013 Zaizi Ltd is registered in England and Wales with the registration number 6440931. The Registered Office is 222 Westbourne Studios, 242 Acklam Road, London W10

More information

federal register Department of Health and Human Services Part II Thursday March 20, 1997 Food and Drug Administration

federal register Department of Health and Human Services Part II Thursday March 20, 1997 Food and Drug Administration federal register Thursday March 20, 1997 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule Electronic Submissions;

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

Dissecting Electronic Signatures for the Life Sciences

Dissecting Electronic Signatures for the Life Sciences Vol. 12, No. 1, January 2016 Happy Trials to You Dissecting Electronic Signatures for the Life Sciences By Robert Finamore and John Harris Electronic signatures (e-signatures) can save substantial time

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

Solution Brief for ISO 27002: 2013 Audit Standard ISO 27002. Publication Date: Feb 6, 2015. EventTracker 8815 Centre Park Drive, Columbia MD 21045

Solution Brief for ISO 27002: 2013 Audit Standard ISO 27002. Publication Date: Feb 6, 2015. EventTracker 8815 Centre Park Drive, Columbia MD 21045 Solution Brief for ISO 27002: 2013 Audit Standard Publication Date: Feb 6, 2015 8815 Centre Park Drive, Columbia MD 21045 ISO 27002 About delivers business critical software and services that transform

More information

Xcalibur. Foundation. Administrator Guide. Software Version 3.0

Xcalibur. Foundation. Administrator Guide. Software Version 3.0 Xcalibur Foundation Administrator Guide Software Version 3.0 XCALI-97520 Revision A May 2013 2013 Thermo Fisher Scientific Inc. All rights reserved. LCquan, Watson LIMS, and Web Access are trademarks,

More information

Guidance for electronic trial data capturing of clinical trials

Guidance for electronic trial data capturing of clinical trials Guidance for electronic trial data capturing of clinical trials 1 st November, 2007 Japan Pharmaceutical Manufacturing Association pg. 1 Table of Contents 1. Background... 3 2. Purpose... 3 3. Scope...

More information

Rackspace Archiving Compliance Overview

Rackspace Archiving Compliance Overview Rackspace Archiving Compliance Overview Freedom Information Act Sunshine Laws The federal government and nearly all state governments have established Open Records laws. The purpose of these laws is to

More information