New to the GMP world and thank you for all the helpful discussion treads so far...
Concerning Part11 GMP compliance: We have controlled (signed hardcopies) of our approved supplier list and equipment/calibration list templates (to name a few), but we are using the soft copy excel version as a living document where one person updates as needed whenever we add a new supplier or equipment, etc. We do not print off and sign a new version with each update of this type. Is this in breach of Part 11 compliance? Should we maintain a hard copy version that gets updated and signed off with each addition to be compliant? Thanks you.
Concerning Part11 GMP compliance: We have controlled (signed hardcopies) of our approved supplier list and equipment/calibration list templates (to name a few), but we are using the soft copy excel version as a living document where one person updates as needed whenever we add a new supplier or equipment, etc. We do not print off and sign a new version with each update of this type. Is this in breach of Part 11 compliance? Should we maintain a hard copy version that gets updated and signed off with each addition to be compliant? Thanks you.