Manual Equipment usage log book for 21 CFR Part 11 equipments

This question is regarding QC Equipment. Is it necessary to maintain manual log books for recording usage, where the subject equipment is already 21 CFR part 11 compliance and all the equipment usage records can be traceable through audit trials.

1 Like

The manual logbooks should be maintained as per GDP, also manual logbooks are relatively easy to access for quick reference, where as audit trail are subject to limited access.

1 Like

Equipment usage log , required to track calibration, cleaning or maintenance or service.