Computer system validation

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Computer system validation

  1. 1. www.PharmInfopedia.com
  2. 2.  Why Computer Validation ?  List of Guidance Documents.  General Principles of Software Validation.  OTS Software Use in Medical Devices.  Electronic Records, Electronic Signatures ( 21 CFR Part 11 )  Guidance Document for Computerized System used in Clinical Trials.  Validation of Electronic Spreadsheet.  Introduction to Validation Master Plan.  Definition of ERP System  Possible Questions  References www.PharmInfopedia.com
  3. 3. www.PharmInfopedia.com
  4. 4. Data and Information Management Systems Problem Solving Applications Communication Aids ( e- MAIL, DIMS ) Laboratory Automation ( LIMS, HPLC, DISSOLUTION, MICROBALANCES ) Process Control Computerised System used for Clinical Trials and Manufacturing of Medical Devices www.PharmInfopedia.com
  5. 5. April 1999 Computerized Systems Used in Clinical Trials September 1999 Off-The-Shelf Software Use in Medical Devices August 2001 Electronic Records; Electronic Signatures – Validation January 2002 General Principles of Software Validation August 2003 Electronic Records; Electronic Signatures - Scope and Application 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 820 Quality System Regulation www.PharmInfopedia.com
  6. 6. Software used as a component, part, or accessory of a medical device Software that is itself a medical device Software used in the production of a device Software used in implementation of the device manufacturer's quality system January 11, 2002, CDRH, CBER www.PharmInfopedia.com
  7. 7. Least Burdernsome and Specific Approach SOFTWARE VALIDATION Validation during each activity of life cycle model 21 CFR Part 820 OTS Software Validation (device manufacturer responsible) Simulated Use Environment and User Site Testing Overall design validation for the system Validation Coverage / Extent of Validation Validation Documentation Self-Validation not followed Validation Master Plan Premarket Submission to : ODE CDRH CBER Postchange Software Validation Documentation Updation www.PharmInfopedia.com
  8. 8. Quality Planning System Requirements Definition Detailed Software Requirements Specification Software Design Specification Construction or Coding Testing Installation Operation and Support Maintenance Retirement www.PharmInfopedia.com
  9. 9. Guidance for premarket submission to FDA 3 Level of Concerns Documentation ( Basic and Special) Corneal Topographer (Minor Level of Concern Device) Implantable Medical Device Programmers (Major Level of Concern Device) September 9, 1999www.PharmInfopedia.com
  10. 10. www.PharmInfopedia.com
  11. 11. 21 C F R P A R T 11  Was issued in March 1997  Records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted  Submission to FDA and also to comply with Predicate Rules (The Act ,The PHS Act)  Three major concerns demanded the revision of 21 CFR Part 11 1. unnecessarily restrict the use of electronic technology 2. significantly increase the costs of compliance 3. discourage innovation and technological advances  Revised and issued in August 2003 www.PharmInfopedia.com
  12. 12. WHAT DOES PART 11 REQUIRE www.PharmInfopedia.com
  13. 13. Records maintained in electronic format in place of paper format (PredicateRules and FDA) No predicate rule requirement but it is in electronic format --- No CFR Part 11 Records maintained in electronic format in addition to paper format (Predicate Rules and FDA) Records maintained in electronic format (Predicate Rules, but not required by FDA) Electronic Record used for generating submission if not required by Predicate Rules is not a part of CFR Part 11 and vice versa Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings (Predicate Rules) www.PharmInfopedia.com
  14. 14. Validation Audit Trail Legacy Systems Copies of Records Record Retention www.PharmInfopedia.com
  15. 15. System Requirements Specifications Documentation of Validation Activity Dynamic Testing Static Verification Techniques Extent of Validation Independence of Review Revalidation www.PharmInfopedia.com
  16. 16. Documentation of user requirements/intended use Computer system implements needs correctly Documentation of Validation Activity Validation Plan Validation Procedure Validation Report www.PharmInfopedia.com
  17. 17. Key testing consideration Testing Condition Normal Stress Actual Performance Testing Simulation Test User-Site Test Software testing Structural Testing (White Box Testing) Functional Testing (Black Box Testing) Program Build Testing www.PharmInfopedia.com
  18. 18. Static analyses Technical reviews Extent of Validation Risk with the system System’s Complexity www.PharmInfopedia.com
  19. 19. Third Party Person of the Organisation Revalidation As per requirement of user By system upgradation During routine servicing and maintenance Network like internet www.PharmInfopedia.com
  20. 20. IS IT NECESSARY TO VALIDATE COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS April 1999 USFDA www.PharmInfopedia.com
  21. 21.  Automating analytical data calculations from various laboratory analyses  Tracking and summarizing product complaints  Gathering and summarizing clinical trial data collection and analyses  Validation of Electronic Spreadsheet is necessary in order to evaluate key drivers : Authenticity, Data and System Integrity, and Confidentiality  Should comply with Predicate Regulations 21 CFR Part 11 www.PharmInfopedia.com
  22. 22. ELECTRONIC SPREADSHEET YEAR OF DEBUT LAUNCHER VisiCalc 1978 Harvad Business School Lotus 1-2-3 1983 IBM Excel 1984 Microsoft Corporation www.PharmInfopedia.com
  23. 23. Preparation of test cases/test procedures for each functional element defined. Test case must challenge the operation and performance of the system especially for its most critical parameters Execution of the test cases and the results must be recorded Evaluate whether software has been validated for its intended use Documented evidence of all testing procedures, test input data, and test results must be retained www.PharmInfopedia.com
  24. 24. "HOW MUCH VALIDATION IS ENOUGH ?" "WHICH SYSTEMS DO WE HAVE TO VALIDATE ?“ “HOW TO COORDINATE THE VALIDATION EFFORTS ?” “HOW TO MAKE VALIDATION EFFORT WITHIN THE BUDGET ?” www.PharmInfopedia.com
  25. 25.  Integrates planning, manufacturing, distribution, shipping, and accounting into a single system  Designed to serve the needs of each different department within the enterprise  Creates supply chain management  An ERP implementation can cost millions of dollars to create, and may take several years to complete  Implement ERP in a more incremental fashion  Tremendous advantages: 1. Share information 2. Workflow becomes more automated 3. It can speed up the manufacturing process by automating processes and workflow 4. It also reduces the need to carry large inventories.www.PharmInfopedia.com
  26. 26.  According to your view point, Why it is necessary to validate “Computer” ? [ 2 marks ]  State the general principles of Software Validation. [ 5 marks ]  What is OTS Software ? How the level of concern affect the documentation of OTS software validation ? [ 2 marks ]  State the key principles of validating Electronic Records and Electronic Signatures. [ 5 marks ]  How will you validate the Electronic Spreadsheet ? [ 2 marks ] www.PharmInfopedia.com
  27. 27. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002. (http://www.fda.gov/cdrh/comp/guidance/938.html) Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices, September 9, 1999. (http://www.fda.gov/cdrh/ode/guidance/585.html) Guidance for IndustryPart 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003. (http://www.fda.gov/cder/guidance/5667fnl.htm) Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation, August 2001. (http://www.fda.gov/ohrms/dockets/98fr/001538gd.pdf) Guidance for Industry, Computerized Systems used in Clinical Trials, April 1999. (http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm)www.PharmInfopedia.com
  28. 28. US Food and Drug Administration, Center for Devices and Radiological Health, Code of Federal Regulations, Title 21, Part 11, Volume 1, Electronic Records and Electronic Signatures, Revised as of April 1, 2005 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=11&showFR=1) Computer Validation Guide, Final Draft, Version 2, December 2002. (http://apic.cefic.org/pub/compvalfinaldraftDecember2002.pdf) Technical Considerations for the Validation of Electronic Spreadsheets or Complying with 21 CFR Part 11 by Taun T. Phan, Pharmaceutical Technology, January 2003. (www.pharmtech.com) Computer Validation Master Planning “Validation Strategies” by Michael Schousboe, Pharmaceutical Technology, November 1, 2005. (www.pharmtech.com) Computers in Pharmaceutical Technology, Encyclopedia of Pharmaceutical Technology, Volume 3. www.PharmInfopedia.com
  29. 29. www.PharmInfopedia.com

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