Part 11 (ERES)

GxP, 21CFR Part 11 (ERES), training, audits, safety, QC/QA, validations

 

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Development of proper documentation

  
  • Quality Assessment
  • Vendor Audits
  • Validation Master Plans & Corporate Policy (VMP)
  • Part 11 Assessment
  • Risk Assessment
  • System Specification Document
  • System Action Plan
  • User Requirement Specifications (URS)
  • Functional Specifications (FRS)
  • Software & Hardware Design Specifications (HDS / SDS)
  • System Configuration Document
  • Validation Protocol
  • IQ, OQ, PQ Test Plans & Cases
  • Test Documentation
  • Incident Logs and Reports
  • IQ, OQ, PQ Report(s)
  • Trace Matrix
  • Validation Report
  • Supporting Documentation
    • Operating / Use SOP
    • Maintenance
    • Cleaning
    • Decommissioning
    • Archiving & Retrieval
    • Backup & Restore
    • Access & Security
    • Contingency & Recovery
    • Training
    • Audits

 

 

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