Pharma-Bio Serv - Computer Systems Validation

By: Pharma-bio Serv  05/12/2011
Keywords: Risk Management, computer systems, Computer Systems Validation

Computer Systems and Software Validation is a requirement of the FDA 21 CFR and EMEA.  Company Policies must be in place to establish the systems methodology to computer validation, combined with a systems based and risk management approach.  Establishment of a successful CSV Policy is accomplished by integrating computer and information technology knnowledge with regulatory requirements.  Self standing and technically sound policies, procedures and validation documents will be the basis to demonstrate reliable and robust validated systems.

  • QRM Approach to Computer Systems: Impact vs. Non-Impact applying QRM 9, ASTM 2500 and GAMP 5
  • Computer Systems Validation Protocols
  • Controls / Automation / Integration
  • 21 CFR Part 11 Gap analysis / Assessment
  • 21 CFR Part 11 Corrective Action Plans
  • System Development Life Cycle Management (SDLC)
  • Control of Changes
  • Computer Validation Master Plans
  • Factory Acceptance and Site Acceptance Tests (FAT / SAT's)
  • User Requirement Specifications (URS)
  • Traceability Analysis Matrix (TM)
  • Functional Specification (FS)
  • Design Specification (DS)
  • Software Vendor Audit & Report
  • C&Q Protocols: IQ, OQ, PQ
  • Source Code Review and Testing
  • Standard Operating Procedures (SOP's)
    • Contingency Plan
    • Change Management
    • Disaster and recovery plans
    • Annual System Review
  • Development Test Plans & Report
  • Validation Reports
  • System Classification Forms
  • Impact Assessment / Risk Management
  • Computer Systems Validation Methodology
  • Computer Systems Validation Procedures

Keywords: computer systems, Computer Systems Validation, Risk Management, software validation

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