Efficient change management runs with configuration management and includes a documented description and business benefit, confirmation of resources, assessment of impact on the application, infrastructure, people and documentation, reuse of the original risk assessment and assessment of new risks to define the compliance strategy including regression testing, evaluation from financial, technical and compliance perspectives at the lowest competent level before management approval, a clear line kept between changes that touch the pharmaceutical quality system and changes to how IT is delivered and serviced, minimal approval points, communicated decisions, execution and verification using traceability to find existing tests, and timely closure. Recognized weaknesses include lack of scalability for minor and routine changes, steps out of sequence, poor scheduling, abuse of emergency change, inability to prevent unnecessary change, stale specifications, failure to reuse risk and traceability information, no follow-up to close records, duplicated processes for equipment and computer systems, misapplied like-for-like principles, poorly managed supplier changes and inadequate follow-up after emergency changes.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.