Changes in 21 CFR (Code of Federal Regulations) Part 11 Subpart C Electronic Signatures § 11.100 General requirements.

Intended to provide guidance on the principles & examples of tools for quality risk management that can be applied to different aspects...

WHO Expert Committee on Specifications for Pharmaceutical Preparations has published the Technical Report Series TRS 1044 2022 56th Report

Requalification shall be carried out to ensure the equipment should be maintained in a qualified state throughout the life-cycle of the same

To check the equipment etc. operates consistently & gives reproducibility within defined specifications & parameters, for prolonged periods

Operational Qualification: Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.