RTM Preparation

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,

I wanted to understand if the RTM should be prepared once the IQ/OQ & PQ test scripts are finalized (Pre Execution) or when the test scripts are executed (Post Execution)?

This is always a confusing for me. But I have kept the practice of creating RTM only after scripts execution? Is that a right approach?

Please suggest…

Regards,
Sourav

2

By RTM, you mean Requirements Trace Matrix?

If so, it would seem to me to be more appropriate pre-execution. Otherwise, how would you know (for protocol approval) that your requirements are fully verified?

I would at least hope that they wouldn’t be different pre-execution -v- post-execution! :slight_smile: