Please could help me to understand if It could be in compliance in Commissioning phase to write a QA Master Document to track the documentation activities of review about building, utilities and instruments?
Thank you
In fact before commissioning phase there should be active involvement of QA team along with QC, Production, Warehoue, Engineering and IT persons, to write following documents,
- User Requirement Specification (URS) of Instruments, equipment (in the QC Lab & Production), Utilities
- Protocols of Design Qualification (DQ) of all above
- Building Management System
- Validation Master Plan (VMP)
- List of plant SOPs
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