Comprehending and adhering to Quality Assurance rules is crucial. High-risk products entail more FDA regulations and audits. FDA guidelines, within Title 21 CFR, include Part 11 for electronic records and signatures, and Part 820 for medical device manufacturing practices in North America.
21 CFR Part 11 Electronic records and electronic signatures
Part 11 sets criteria for trustworthy electronic records and signatures. Life Science firms must maintain the latest documents with a clear audit trail detailing changes. Auditors consider validation, timestamps, record maintenance, and electronic copies per 21 CFR Part 11.
21 CFR Part 820 Good manufacturing practices
21 CFR Part 820 outlines CGMP for medical device firms. All processes related to products must be documented in the eQMS, including facility methods and controls. An eQMS serves as a quality foundation in Life Science, offering peace of mind to professionals and the organization by efficiently managing and documenting business processes for quality, compliance, and product development.