Computer System Validation CSV in pharmaceutical

Computer systems validation CSV in pharmaceutical industry

We can define, organize and perform the entire process of computer systems validation in pharmaceutical industry according to standard operating procedures (SOP). The computer validation performed by us is in accordance with the regulations of GAMP, FDA, 21 CFR Part 11 and EudraLex - Volume 4 GMP guidelines Anex 11 about Computerised Systems. We prepare validation plans VP, quality project plans QPP and implement IQ, OQ, PQ test protocols as issuing a final qualification summery report QSR.

The preparation of a sufficiently good plan for validation or verification directly affects the quality of the validation process. We can define, organize and execute the entire process.

We demonstrate a concise content of a computer validation plan below:

  • Purpose and Scope of CSV
  • Organization, Roles and Responsibilities of the Qualification Team
  • Description of Project
  • Process Systems
  • Process Supporting Systems
  • Data Migration
  • Quality Risk Management Approach
  • Managing Changes
  • Maintenance Management
  • Alarm Management
  • Qualification Approach

- Qualification Project Phases

- Installation & Operational Qualification (IQ/OQ)

- Performance Qualification (PQ)

  • Supplier Assessments
  • Attachments to Qualification Documents
  • Format of Qualification Protocols and Reports
  • Management of Qualification Documents
  • Reference Procedures
  • Qualification Project Summary Report (QSR)
  • Abbreviations
  • References
  • Appendices

For more details contact us.


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