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What is GMP DMF/CoS/CMC GAP Analysis Process Validation Qualification Training
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Computer Systems Validation
Purpose
To establish documented evidence that provides a high degree of assurance that computerized systems which could have an impact on product quality (e.g. ERP, DCS, PCS, LIMS, Excel Spread Sheets) will consistently perform as intended in their operational environment according to predetermined specifications and quality attributes and to assure that recorded data and information are safe and unchangeable.
Prerequisites
  • Basic GMP system should be implemented
  • Intended use of IT-systems should be clear (e.g. ERES requirements)
  • Validation / qualification system (SOPs) should be in place.
  • Staff taking part in validation work should have been appropriately trained.
  • Discussions with client are required throughout the whole validation process.
Procedures
  1. Discuss with client about their requirements (kind of systems and their use) and collect the required information for quotation (Signing of Secrecy Agreement recommended).
  2. Prepare an offer (fixed rate difficult, depends on the no., kind and use of GMP relevant IT systems).
  3. Sign the contract and project commence.
  4. Nominate a Validation Team.
  5. Prepare a Validation Master Plan (VMP) specific for CSV.
  6. Prepare basic SOPs for computer systems validation if not yet available
  7. Prepare User Requirement Specification (URS) for prospective validation.
  8. Collect and collate all existent IT-systems for retrospective validation
  9. Perform a risk analysis to identify the GMP-relevant IT systems to be validated including a SW categorization acc. GAMP compliance.
  10. Prepare a Project Plan Validation (PPV) including a traceability matrix
  11. Prepare Validation Protocols and test specifications for approval by client.
  12. Perform HW and SW tests including black box and white box testing
  13. Perform integrity tests followed by system OQ and PQ tests
  14. Collect and collate all generated test records and printouts
  15. Prepare a summary of history, problems in the past and activities performed by the IT systems for retrospective validation.
  16. Discuss the results within the validation team and evaluate all deviations.
  17. Do the corrective actions if necessary and revalidate
  18. Prepare the Validation Report for approval by client.
  19. Compile all the relevant documents in the Validation Master File.
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