Intland s Medical Template

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Intland s Medical Template"

Transcription

1 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 and more

2 INTLAND codebeamer ALM is built for Medical Device Medical device development teams are faced with increased software complexity when developing high quality devices. It is essential to manage risks and meet industry safety standards in order to ensure patient safety. The medical industry is highly regulated with standards to define and ensure software quality and to control risks. IEC codebeamer Medical ALM assists manufacturers in achieving compliance with the international standard IEC 62304, the mandatory regulation for manufacturers of medical devices. It also supports compliance with FDA Title 21 CFR Part 11 for manufacturers and developers in the US market. codebeamer Medical ALM provides the full functionality of a complex ALM solution. It includes requirements, development and test management, all customized to meet the needs of users in the medical field. codebeamer ALM is built for Medical Device Development and for Regulatory Compliance (IEC 62304, US FDA Title 21 CFR Part 11)

3 codebeamer ALM is built for Medical Device INTLAND Configured for Medical Lifecycles Quality, requirements, design, test, configuration and change management features and all artifacts are preconfigured for medical processes to ensure full traceability and auditability throughout the complete development lifecycle, in order to help you achieve compliance with IEC and/or FDA 21 CFR Part 11. Medical Requirements Management Customers, systems, software and architecture-related trackers are defined to capture and manage all requirements of the medical device. The integrated Traceability Browser shows the dependencies among requirements and risks, as well as all other work item types. Risk Management & FMEA codebeamer s medical risk tracker comes with a preconfigured, customizable risk management workflow. A Failure Mode and Effects Analysis (FMEA) template is available to help identify, prioritize, and plan the mitigation of risks. Risk Matrix Diagrams give you an overview of your overall risk levels. Medical Wiki The medical wiki fully supports compliance with IEC as its content covers the standard requirements. The medical wiki provides the users of codebeamer s Medical Project with domain knowledge and it supports the application of rules throughout the entire development lifecycle.

4 INTLAND codebeamer ALM is built for Medical Device Medical Document Management with Templates The document management module is equipped with template documents and process descriptions based on the requirements stipulated by the standard IEC Integrated QA & Test Management QA & Test Management is integrated in the ALM solution, letting you conveniently manage testing and quality assurance. Test cases can be generated automatically from requirements, stored in test sets, and saved in the test case library for reuse. A Test Coverage Browser is available to help you ensure complete test coverage. Release Management codebeamer s release management functionality enables you to plan your releases (milestones, versions) in a convenient way, to add requirements to sprints using a simple drag-and-drop interface, and to monitor the progress of your processes.

5 codebeamer ALM is built for Medical Device INTLAND Advanced Workflows & Process Enforcement codebeamer s advanced workflows allow you to customize your processes by configuring your own workflows. You can also set up your workflows to automatically create work items if certain conditions are met. For instance, if a requirement with a high safety rating is submitted, the system can be configured to automatically create a risk and a test case, ensuring these high-risk items are adequately managed. Workflow visualization helps trace and prove development processes, greatly facilitating compliance. Process Guards & FDA-compliant E-signatures Guards with conditions may also be added to workflows, and e-signatures may be required for certain steps in the process. This helps ensure that all necessary approvals are done by the appropriate members of your team, and that only authorized personnel can change or add items (naturally, all changes are recorded and documented). codebeamer s e-signatures support compliance with FDA Title 21 CFR Part 11, as they store all the relevant data about user authorization & the e-signature in human readable format.

6 Compliance with IEC codebeamer function Chapter of IEC Trackers Configuration Items Medical Wiki Document Management SCM Repositories Reports Test Management 4 General requirements 4.1 Quality management system Defined in corporate documentation 4.2 Risk management l l 4.3 Software safety classification l l 5 Software development process 5.1 Software development planning l l Software development plan, updates, definition of standards methods and tools. Test and verification planning, risk management, documentation and configuration planning. 5.2 Software requirements analysis l l l l System-Software-requirements definition, risk control measures, risk evaluation and mitigation. 5.3 Software architectural design l l l Architecture requirements, SOUP definition, hardware requirements, risk control measures and verification. 5.4 Software detailed design l l l Design for software units, interface design, software unit implementation, verification and acceptance. 5.5 Software unit implementation and verification l l 5.6 Software integration and integration testing l l Software integration and integration testing, software units integration, test inteagration, verification, regression test, problem resolution process. Design for software units, interface design, software unit implementation, verification and acceptance. 5.7 Software systems testing l l 5.8 Software release l l l l Software release verification, evaluate residual anomalies, documentation task completation report, archive and repeatability of software releases. 6 Software maintenance process 6.1 Establish software maintenance plan l l 6.2 Problem and modification analysis l Feedback documentation, evaluation and monitoring, safety problem reports, change request analysis, CRQ approval, communication to users. 6.3 Modification implementation l l Use established process to implement modification, re-release modified software system. 7 Software risk management process 7.1 Analysis of software contributing to hazardous situations l l Identify software items that could contribute to a hazardous situation and potential causes of contribution to a hazardous situation, evaluate published SOUP anomaly lists and prepare documentation. 7.2 Risk control measures l l Define risk control measures, and implement risk control measures in software development. 7.3 Verification of risk control measures l l Identify software items that could contribute to a hazardous situation and potential causes of contribution to a hazardous situation. 7.4 Risk management of software changes l Analyse changes to medical device software with respect to safety, analyse impact of software changes on existing risk control, perform risk management activities based on analyses. 8 Software configuration management process 8.1 Configuration identification l l Establish means to identify configuration items, identify SOUP, identify system configuration documentation. 8.2 Change control l l Approve change requests (CRQ), implement and verify change, provide means for traceability of changes. 8.3 Configuration status accounting l l 9 Software problem resolution process 9.1 Prepare problem reports l l 9.2 Investigate the problem l l 9.3 Advise relevant parties l l 9.4 Use change control process l l 9.5 Maintain records l l 9.6 Analyse problems for trends l l 9.7 Verify software problem resolution l l 9.8 Test documentation contents l l

7 Compliance with US FDA Title 21 CFR Part 11 Chapter in FDA FDA regulation Original Text codebeamer compliance Subpart B Electronic Records a Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. All artifacts/records in codebeamer can be tracked and traced via history data. Permission control can be used to ensure only those with authorization can access data 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. All documents in codebeamer can be exported to readable industry standard formats. ReqIF and MS Office integration is fully supported, including export and roundtrip export-import functionality c Protection of records to enable their accurate and ready retrieval throughout the records retention period. All data is stored in the database (MySQL or Oracle) that can be regularly saved and maintained even during software upgrades. Electronic records with electronic signatures are stored in the database d Limiting system access to authorized individuals. System administration security rules are fully supported by codebeamer. All administrative changes are recorded e Use of secure, computer-generated, 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. All date and time information regarding creating, modifying or deleting artifacts in codebeamer are logged. Full change history is saved (what was edited by whom, at what point in time). Log files can be exported and supervised by authorized administrators. Electronic signatures attached to records are maintained f Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. Using workflows, a fixed sequence of steps and events as well as status transition rules can be set up in codebeamer in order to enforce certain processes 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. Security experts are contracted to test codebeamer. Industry standard user authentication, single-sign-on, and role based access is provided to manage system access and record modification. Electronic signatures can be enforced h Use of device (e.g. terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction. Guards with workflows are provided for data source validation 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. It is the responsibility area of the company that is in charge of the maintenance and management of the system. This documentation is a part of FDA 21 CFR QM system docs 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. It is the responsibility area of the company that is in charge of the maintenance and management of the system. Thus, it is not a system requirement k 1.) and 2.) Use of appropriate controls over systems documentation including: Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. Revision and change control procedures to maintain an audit trail that documents time sequenced development and modification of systems documentation. All documents are managed by codebeamer s integrated document management system. The same rules and system features are applicable for documents that are marked under e. (i.e. all changes, modifications etc. are recorded and logged). Revision and change control are available in the document management subsystem, documents are stored in the active database a Signature manifestation Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: 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. Electronic signature in codebeamer contains the following data: The printed name of the signer; The date and time when the signature was executed; and 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 signature records can be displayed in human readable format Signature record linking 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. Electronic signatures are linked to the adequate electronic record (artifact). They can not be removed, deleted, or attached to another artifact.

8 Compliance with US FDA Title 21 CFR Part 11 Chapter in FDA FDA regulation Original Text codebeamer compliance Subpart C Electronic Signature a Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. codebeamer requires a User name (ID) and password to issue electronic signatures. All electronic signatures are generated as unique. The same signature can not be generated twice. User ID and password are required to authenticate the identity of users. All electronic signatures that are successfully created are logged and recorded in the system and are attached to the electronic records 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. The procedure has to be defined and executed by the company. This can be enforced with the organization s AD system. 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. This has to be managed by the company and can be enforced by their AD system c 1. The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFCJ100), 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 1,2,3 Electronic signatures that are not based upon biometrics shall: 1. Employ at least two distinct identification components such as an identification code and password. ( 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. ( 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. 2. Be used only by their genuine owners; and 3. Be administered and executed to ensure that attempted use of an individual s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. codebeamer requires a User name (ID) and a password to issue each and every electronic signature. All electronic signatures are generated as unique, meaning that authentication is required every time a signature is issued b Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). codebeamer can be configured so as to make sure that ID codes and passwords need to be changed periodically. This can be enforced via the organization s AD system 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. It has to be regulated by the company and measurements have to be taken 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. Unauthorized access after a number of failed logon attempts can be automatically configured to alert maintenance administration. Notification are sent via . All failed logon attempts are recorded and reports are generated. Further prevention can be enforced with the organization s AD system 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. This is outside the scope of use of codebeamer; has to be regulated by the company.

9 codebeamer ALM is built for Medical Device INTLAND Main Benefits of codebeamer Medical ALM codebeamer Medical ALM has been designed for use in the medical industry to support compliance with IEC 62304, IEC & relevant FDA regulations. Manufacturers of medical devices can benefit from significant cost savings both in terms of time and effort, gapless end-to-end traceability, and complete process control to facilitate compliance. The medical template is flexibly configurable and can be customized to suit all internal processes and practices. It also offers document management and reporting features to help prepare for compliance audits. Access to domain knowledge: codebeamer s Medical Project has been developed with domain experts and contains in-depth domain knowledge based on the IEC standard and available practices. codebeamer Medical ALM offers a wealth of medical knowledge, a collaborative development platform, and advanced medical process capabilities to support the development of high quality, reliable medical devices, and to help prepare for compliance audits. For further details please visit our website:

10 INTLAND codebeamer ALM is built for Medical Device codebeamer ALM at a Glance Demand Management l Project & Portfolio Management (PPM) l Requirements Management l Change and Configuration Management l Test and QA Management l Document Management and Versioning l Workflow Management l Web-based Collaboration l

11 Intland Software is a dynamically growing player in the Application Lifecycle Management market. It is our mission to help you achieve higher quality processes in your software development efforts. codebeamer, the Jolt award-winning development suite from Intland Software assists you in managing your requirements and specifications from requirements all the way through to release. Our medical references: Free download:

codebeamer INTLAND SOFTWARE codebeamer Medical ALM Solution is built for IEC62304 compliance and provides a wealth of medical development knowledge

codebeamer INTLAND SOFTWARE codebeamer Medical ALM Solution is built for IEC62304 compliance and provides a wealth of medical development knowledge codebeamer Medical ALM Solution is built for INTLAND Traceability matrix Medical wiki Risk management IEC 62304 compliance codebeamer INTLAND codebeamer Medical ALM Solution is built for Medical Device

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

Requirements Management

Requirements Management MS Excel / Word, and ReqIF Export / Import and Round-trip Medical & Automotive Requirements and Risk (FMEA, IEC 62304, IEC 61508, ISO 26262...) Enterprise Architect and Atlassian JIRA integration Requirements

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

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

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

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

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

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

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

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

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

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

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

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

Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support

Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support Overview codebeamer is a single-repository Application

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

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

Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support

Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support Demand & Requirements Management Software Development QA & Test Management IT Operations & DevOps Change Management Agile, SAFe, Waterfall Support Workflows with Business Process Management capabilities

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

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

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

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

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

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

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

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

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

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

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

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

DATATRAK Customer Case Study

DATATRAK Customer Case Study DATATRAK Customer Case Study DATATRAK: A Success Story of Traceability and Process Transparency This case study explores how DATATRAK International, Inc., a company offering software solutions and consulting

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

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

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

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

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

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

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

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

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

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

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

Software Development. Overview. www.intland.com

Software Development. Overview. www.intland.com Agile, Waterfall & Hybrid Method Support SAFe Template Git, SVN, Mercurial Integration Release Management DevOps Baselining (Versioning) Integration to Requirements and QA & Testing Overview codebeamer

More information

Change & Configuration! Management

Change & Configuration! Management Change & Configuration Management 100% Web based Word & Wiki Authoring Baselines and Versioning Process Enforcement Requirement Traceability Requirement Workflows Advanced Collaboration Services Integration

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

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

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

Medical Device Software - Software Life Cycle Processes

Medical Device Software - Software Life Cycle Processes 1 Medical Device Software - Software Life Cycle Processes IEC 62304 2 Credits John F. Murray Software Compliance Expert U.S. Food and Drug Administration Marcie R. Williams Medical Device Fellow Ph.D.

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

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

Analyst. LC/MS Software and 21 CFR Part 11 Regulations PURPOSE INTRODUCTION WHAT IS 21 CFR PART 11? CONTENTS

Analyst. LC/MS Software and 21 CFR Part 11 Regulations PURPOSE INTRODUCTION WHAT IS 21 CFR PART 11? CONTENTS 21 CFR PART 11 REGULATIONS Analyst LC/MS Software and 21 CFR Part 11 Regulations PURPOSE The purpose of this paper is to present an approach to assist the user in meeting 21 CFR Part 11 compliance with

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

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

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

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

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

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

FDA Software Validation-Answers to the Top Five Software Validation Questions

FDA Software Validation-Answers to the Top Five Software Validation Questions Whitepaper FDA Software Validation-Answers to the Top Five Software Validation Questions Author: Penny Goss, Penny Goss Technical Solutions The FDA (Food and Drug Administration) and IEC (International

More information

CoSign for 21CFR Part 11 Compliance

CoSign for 21CFR Part 11 Compliance CoSign for 21CFR Part 11 Compliance 2 Electronic Signatures at Company XYZ Company XYZ operates in a regulated environment and is subject to compliance with numerous US government regulations governed

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

QA & Test Management. Overview. www.intland.com

QA & Test Management. Overview. www.intland.com Agile, Waterfall & Hybrid Method Support SAFe Template for Scaling Agile Git, SVN, Mercurial Integration Release IT Operations & DevOps Baselining (Versioning) Integrated with requirements and QA & Testing

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

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

Pharmaceutical, Biotech and Medical Device Manufacturers. Be Compliant and Audit Ready - Implement an LMS!

Pharmaceutical, Biotech and Medical Device Manufacturers. Be Compliant and Audit Ready - Implement an LMS! Pharmaceutical, Biotech and Medical Device Manufacturers Be Compliant and Audit Ready - Implement an LMS! Organizations in the life sciences industry such as pharmaceuticals, medical devices and biotech

More information

Comparison of FDA s Part 11 and the EU s Annex 11

Comparison of FDA s Part 11 and the EU s Annex 11 Introduction The relationship between FDA s (21 CFR ) and the European Union s (EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products

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

05.0 Application Development

05.0 Application Development Number 5.0 Policy Owner Information Security and Technology Policy Application Development Effective 01/01/2014 Last Revision 12/30/2013 Department of Innovation and Technology 5. Application Development

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

Shiny Server Pro: Regulatory Compliance and Validation Issues

Shiny Server Pro: Regulatory Compliance and Validation Issues Shiny Server Pro: Regulatory Compliance and Validation Issues A Guidance Document for the Use of Shiny Server Pro in Regulated Clinical Trial Environments June 19, 2014 RStudio, Inc. 250 Northern Ave.

More information

Integrity 10. Curriculum Guide

Integrity 10. Curriculum Guide Integrity 10 Curriculum Guide Live Classroom Curriculum Guide Integrity 10 Workflows and Documents Administration Training Integrity 10 SCM Administration Training Integrity 10 SCM Basic User Training

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

SOLAARsecurity. Administrator Software Manual. 010508 Issue 2

SOLAARsecurity. Administrator Software Manual. 010508 Issue 2 SOLAARsecurity Administrator Software Manual 9499 400 40011 010508 Issue 2 2008. All rights reserved. SOLAAR House, 19 Mercers Row, Cambridge CB5 8BZ.United Kingdom. Telephone +44 (0) 1223 347400, Fax

More information