When installing your QMS, you must develop your own Computer System Validation (CSV) and Software Development Life Cycle (SDLC) process to demonstrate the software is validated to your company’s specific requirements.
Even if you’re using off-the-shelf software, you’ve likely made some kind of configuration change during installation. While software companies often provide URS, PQ and User Acceptance Testing (UAT) documentation, you are responsible for updating these documents to reflect how you configured the system during implementation. Key steps include:
- Updating and approving the URS and Traceability Matrix
- Updating and approving the PQ/UAT documents.
- Executing the updated PQ/UAT.
- Including the PQ/UAT documents in the validation plan or report.
- Including any discrepancy items and corrections.
- Saving the documents according to your record retention policies.
