Company: Sunrise Pharmaceutical, Inc Date: 1/14/10 Product: Pharmaceuticals Your firm has not exercised appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel [21 CFR 211.68(b)]. For example, your firm lacks systems to ensure that all electronic data generated...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.