Activity

  • bb254 replied to the topic Simulation 1: Faulty Quality System in the forum Device Documentation 7 years, 2 months ago

    While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up creating a lot more work in the long run. Just to update one document, multiple other documents must be updated to state the new revision of the document. Good manufacturing practices requires the need to make these edits, but it takes away a lot of time. The edit seems to be minute but from this weeks simulations one will realize how many documents need to be updated due to a revision change. Its better to omit the revision of the document when references a procedure or specification.

    Reference:
    https://www.ispe.org/initiatives/regulatory-resources/gmp