使用变色龙7色谱数据系统遵循CFR第11部分

21 CFR Part 11 established requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and equivalent substitutes for paper records and traditional handwritten signatures. Commonly known as Part 11, it requires Food and Drug Administration (FDA)-regulated industries, including medical device manufacturers, drug makers, biotech companies and biologics developers, to have validation documentation and implement controls such as audit trails and electronic signatures. The requirements apply to software and systems involved in processing electronic data that are required to be maintained by or used to demonstrate compliance with FDA predicate rules.