Manufacturing Deviation Software
Manufacturing deviation software facilitates compliance with FDA's 21 CFR Part 211, 21 CFR Part 820, and 21 CFR Part 11 requirements.
Contract research or manufacturing organizations (CxOs) are subject to the same rigorous FDA regulatory requirements as the pharmaceutical and medical device companies that sponsor them. CxOs that help make medical devices are covered by the FDA's 21 CFR Part 820 and they are likely to be certified to ISO 13485 if they sell their products overseas. CxOs contracted by pharmaceutical companies must comply with such regulations as 21 CFR Parts 210-211. Contract organizations that maintain electronic systems like manufacturing deviation software to comply with predicate rules also do meet 21 CFR Part 11 requirements surely.