Life Sciences Paper RSMACC paper - AUTOWEST 2004

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Anyone keeping an eye on the US Food and Drug Administration (FDA) has undoubtedly noticed the Agency's continual changes to the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). In February 2003, the FSA issued a notice that it would re-examine 21 CFR Part 11 and make new recommendations on requirements for validation, audit trails, record retention, record copying, and legacy systems. In the meantime, despite any changes the FDA is considering to 21 CFR Part 11, adhering to internal documentation standards and implementing an integrated electronic document and change management system can enhance your process, manufacturing, and help you address future regulatory challenges.

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