Source: http://www.labcompliance.com/usersclub/preview/computer.aspx
Timestamp: 2017-07-27 06:55:54
Document Index: 643149494

Matched Legal Cases: ['art 11', 'art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 4', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Computer / Software Validation
Click here to download documents in this section
Click here to download documents in other sections
Reference papers and Presentations- private authors FDA regulations and official FDA Guidelines Other regulations, official guidelines and advice from industry task forces Presentations, publications, interviews with FDA personnel
Equipment qualification Network Qualification/Internet
Auditing a Suppliers Equipment Master Validation Plan
S-231-01.
Supplier Assessment According to ASTM E2500
Handling Deviations during Equipment and Computer System Testing
Developing a Gap Analysis for Software and Computer System Validation S-249
Developing an effective Supplier Program to Assist Regulated Users
S-251-01
Selecting the Right Software and Equipment Supplier for Compliance S-251-02
Development of Requirement Specifications for Computer System
The first and most important step of validation and qualification is writing the specifications. Without clear specifications computer systems cannot be fully tested. Well-written System Requirement Specifications (SRS) or User Requirement Specifications (URS) facilitate all consecutive validation/qualification steps and help to meet business objectives. The SOP applies to the development of Requirement Specifications (URS or SRS) for Computer Systems used in GxP regulated environments.
Periodic Evaluation and Review of Computerized Systems
Change Control of Software and Computer Systems
Computer hardware and software are frequently changed. Insufficient documentation and uncontrolled changes can have a negative effect on the reliability of software and computer systems. This SOP should help ensure that changes computer hardware, firmware, software and computer systems follow documented procedures. It describes procedures for initiation, implementation, approval and documentation of the changes.
Quality standards, regulatory agencies and some company policies require software used for evaluation of critical data to be properly validated. Spreadsheet applications are considered as software and should be validated to demonstrate suitability for their intended use. The purpose of this operating procedure is to ensure that Spreadsheet applications are validated during their development and installation and periodically reevaluated during operation.
Using Macros and Spreadsheets (M&S) in a Regulated Environment
Development and Use of Spreadsheets in Part 11 and GxP Environments
S-266 SOP
Validation of Electronic Laboratory Notebooks
Validation of Electronic Document Management Systems S-270
Documentation is a valuable asset to any company as it can contain information, which if lost or altered may be critical for the company. Electronic Document Management Systems (EDMS) control and retain documents from creation, use, maintenance and storage, through to archiving and retrieval. The trustworthiness and integrity of electronic information is dependent on the reliability and integrity of the EDMS. Validation helps to achieve proper design, development, installation and use of EDMS and is a requirement of regulations. This SOP gives guidelines on how to validate Electronic Document Management Systems.
Users of software and computer systems are responsible for validation. This includes validation during development. User firms can delegate part of this validation to vendors of the software or computer systems. User firms should check through a formal vendor assessment process if vendors develop and validate software and computer systems according to regulatory requirements and industry practices. User firms should find the most efficient method for assessment. This can range from simple documentation of experience with the vendor through direct vendor audit. This SOP guides user firms through this assessment process.
S-277 SOP
Qualification of PC Clients
PCs that are part of a network should be qualified. This SOP is intended to qualify PC clients in the most economic and efficient way possible. It applies to PC clients as part of a client server network.
Using Cloud Computing in Regulated Environments
Regulations and company policies require records to be available for up to 10 or more years. Ensuring the authenticity, reliability and long-term availability of electronic records is challenging because they can be easily altered. This procedure should help to reliably maintain and retain electronic records over the entire retention period. It applies to the entire retention period of records as required by applicable regulations and company policies.
Templates / gap analyses / checklists / case studies
Useful Excel Functions and VBA Code to Improve Quality and Compliance of Workbooks E-131
Revalidation of Computer Systems
Periodic Evaluation and Review of Computerized Systems E-148-01
What Regulated Users should expect from Suppliers of Equipment and Computer Systems
E-148-06
What Equipment and Computer System Suppliers should offer to Regulated Users E-148-07
Supplier Quality Agreement E-149-01
EU/PICS GMP Annex 11: Version 2011
E-152_01 Checklist
Gap Analysis/Checklist: User Requirement Specifications for Software and Computer Systems
User Requirement Specifications is the most important validation document for computer systems. Inadequate or incomplete specifications can have a high negative impact on later validation phases and when using the system. This checklist should help to identify User Requirement Specifications. Validation and controls are specific for each system
Laboratory computer systems used in regulated environments should be validated and well controlled. This form helps to identify qualification and validation requirements for software and computer systems
Network Infrastructure Qualification and System Validation
Retrospective Validation of Computer Systems
Commercial Off-the-Shelf Computer Systems
Commercial Off-the-Shelf computer systems used in regulated environments should be validated and well-controlled. This checklist should help to identify qualification and validation and to control software and computer systems. Validation and controls are specific for each system. Therefore going through checklists does not mean that everything is covered for each system nor does it mean that all checklist items are applicable for every system.
Using Computers in FDA Regulated Environments
Computer validation documents
Documents that should be developed before, during and after computer validation.
Master Plan - Template and Examples
Computer System Retirement Plan
Requirement Specifications (without VBA)
Real example for a URS of Spreadsheet Applications. You can also use this as a template for other programs.
Program and Validation Package for MD5 hash calculations
Simple example for complete validation package
MD5 hash calculations can be used to verify data file integrity. Regular or occasional checks of file integrity are recommended for software installation, data archiving, network transactions and e-mail transfer. This ZIP file includes an easy to use program that can be used to learn about the concept and for simple manual operations. It also includes procedures and protocols to test the program and a procedure on how to use the program to verify integrity of e-mail attachments. There is also a 21 page technical description with code and implementation reference for those who want to write their own program.
Software/Computer System Vendor Assessment
Identification of computer systems. E-322
This document is a must for installation qualification (IQ)
This is a complete 29 pages functional test script for an Excel Spreadsheet. It includes a test schedule, two different test traceability matrices and 12 functional tests with test procedures, acceptance criteria and actual results. Test results are summarized in a summary sheet. You can also use this as a template for other programs.
Risk Assessment - HPLC System - HPLC System E-711-03
Requirement Specifications - Document Management System
E-741-02
Supplier Assessment - Document Management System
E-741-04
Test Plan - Document Management System
E-741-06
Installation Qualification - Document Management System
E-741-07
Performance Qualification - Document Management System
E-741-09
Document Management System - Validation Report E-741-11 Example
Step-by-Step Validation - Spreadsheet Applications E-745-00
Test Plan - Spreadsheet Applications
E-745-06
Chromatography Data System - Validation Project Plan E-781-01
Test Plan - Chromatography Data System
E-781-06
Performance Qualification – Chromatography Data SystemE-781-09
Documenting Training – Computer Validation
Vision for Computer System Validation K-1315
Computer System Validation - Policy K-1318
K-1323
Documenting Deviations of Computer System Reviews K-1359
Documenting Corrective Actions of Computer System Reviews K-1360
Computer System Incident Report K-1361
Documenting Computer System Validation Audits
K-1366
Identification of Projects with Highest Potential for Cost Savings
Reporting Test Deviations
Master Plan/Examples
Retirement Plan for Computer Systems
33 Computer and Software Clauses in ISO 17025 - And recommendations for Implementation
Reference Paper: Support from Instrument Vendors for Compliance A-109
written by L.Huber
published in PharmCanada, written by L.Huber
The Future State of Computer Validation, Part 1 and Part 2
Written by nine world experts on computer validation
Qualification and validation of software and computer systems in laboratories
Part 1: Validation during development,
Part 2: Qualification of the vendor
Qualification and validation of software and computer systems in laboratories, Part 3: Installation and Operational Qualification
Qualification and validation of software and computer systems in laboratories,
Part 4: Evaluation and validation of existing systems
Part 11 and Annex 11
The table relates requirements of FDA's 21 CFR Part 11 to Annex 11 of the EU/EC GMP directive.
Guideline On the use of electromagnetic records and electronic signatures in applications etc. for approval or licensing etc. of drugs etc. English version published in 2005
Ready for a Computerized System Validation Audit
David Bergeson, former FDA expert for computer validation. Presentation
Operational Compliance of Legacy Systems
FDA's expectations, enforcement practices and examples of warning letters. Nine steps for implementation
Validation of equipment hardware, software and computer systems
Do you need to train yourself or your people on how to validate and qualify equipment and computer systems? This presentation with many graphic is an ideal way to start.
Computer Systems & Software Validation
The expectations and observations of a European Inspector
Presented at the IVT CSV Conference, Amsterdam, December 2006
It rarely happens that inspectors from Europe give presentations at public conferences. However this happened at IVT's European Annual Computer System Validation Conference on December 5-7 in Amsterdam with Ludwig Huber as chair person. Malcolm Olver from UK's MHRA gave a presentation with the title: Computer Systems & Software Validation: The expectations and observations of a European Inspector. Mr. Olver explained the audience the regulatory framework presented lists with questions typically asked during inspections. Key point of the observations has been that the Validation Master Plan (VMP) typically is raised too late in the project. He also noted that frequently testing is not related critical functions of the process. Most deviations have been related to inadequate change control, for example, lack of control of software upgrades and no recommendations for revalidation
"Electronic Records; Electronic Signatures
FDA General Principles of Software Validation (for Medical Devices)
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.
Guide to inspections of computerized systems in the food processing industry
September 2004 (Draft)
Glossary of computerized system and software development technology
Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software F-387
Office of Regulatory Affairs Compliance References: Bioresearch Monitoring (BIMO) Compliance Program 7348.808
The intent of this attachment is to collect, in one place, references to computer systems of the program
Chapter 22C: Inspection of Computer Systems
This 10 page document is not new but still shows FDA' basic expectations for computer systems, not only for GMP. The objective is that readers will: understand how the GMPs are applied to computer systems, know the similarities and differences between computer systems and other systems, comprehend what is meant by validation of computer systems, know one method for conducting an inspection of a computer system
The FDA received responses from 36 organizations and individuals, with more than 650 questions, comments or specific recommendations for changes. FDA's comments are useful to understand FDA's current thinking on specific aspects of software validation
Using Computerized Systems in Clinical Investigations
May 2007 (Final))
The guidance document has been withdrawn from the FDA website mainly because all existing part 11 guidance documents have been withdrawn in February 2003. However there is absolutely nothing wrong with this guidance. Other regulations, official guidelines and recommendations from industry task forces
Annex 11 of EU GMP
Annex 11 of the EU GMP directive specifies requirements for computers used in GMP regulated environments. To some extent the requirements are similar as FDA's 21 CFR Part 11.
AVP Interpretation of EU GMP Annex 11
Interpretation Annex 11 of the EU GMP directive specifies requirements for computers used in GMP regulated environments. The International Association for Pharmaceutical Technology (AVP) has developed this 27 page interpretation guide for easier implementation.
Annex 11 of the EU GMP directive specifies requirements for computers used in GMP regulated environments. To some extent the requirements are similar as FDA's 21 CFR Part 11. The new version ha
Japan GMP Guideline - Using Computers in GMP Environment
Presentations, publications, interviews with FDA personnel (these are not official guidelines
This presentation is very much up-to-date and has lots of good FDA recommendations for computer validation.
Update on FDA Part 11 Validation Guidance: Computer System Validation and E-records/signatures,
P.Motise, IVT Conference Arlington, April 2002: This presentation is very much up-to-date and has lots of good FDA recommendations for computer validation.
How to Take a Risk-based Approach to Computer Validation in an FDA Regulated Environment
George Smith, Consumer Safety Officer at CDER, US FDA, IVT Conference Arlington, April 2007: Main topics of the presentation are: Why a risk based approach and how we arrived where we are, understanding what's coming to proceed with validation efforts, choosing which system to validate and appropriate levels of validation based on predicate rule. At the end Mr. Smith also gives an update on the status of the new Part 11 regulation.
FDA Information Bulletin
Spreadsheet Design and Validation for the Multi-User Applications for the Chemistry Laboratory
Spreadsheet Design, Verification and Validation, Use and Storage in FDA Laboratories
US FDA FDA Presentation Script
B. Fitzgerald, Deputy Director, CDRH, FDA: Hot Topics: Virtualization and Cloud Computing, Presented at the Workshop, FDA Blood establishment computer software, Maryland , USA G-415