What is the importance of the QA unit in validation of a system?

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,

Cool site, can someone give me abrief description of how the QA unit should fit into the overall validation process. Not sure how many hats out QA unit should wear?

Regards

Timmy

2

Hi Timmy

  • Reviewing and approving the validation policy, validation guidelines and validation procedural controls.

  • Reviewing the computer system validation work and documentation and signing to verify the correct execution of the validation plan, protocols, and summary report for computer systems performing regulated operations.

  • Assessing the compliance of computerized systems to the validation policy, validation guidelines, validation procedural controls, and to related predicate regulations.

  • Auditing and readiness of a computer system for a regulatory inspection

  • Documenting the results of audits in QA audit reports.

  • Ensuring that any audit report issues are resolved

  • Organizing capability assessments on external and internal suppliers

Hope that makes it clear