Electronic Document Management Systems maintaining

Will electronic data management solve all your problems No, you will still need to maintain hard copy sets of procedures. As long as there are power outages and failed computers, hard copies should be maintained. An electronic document management system will, at the least, help you keep your hard-copy sets current and intact. 

Section 21 CFR Part 11.10(e) requires persons who use ERMS to maintain audit trails to protect the authenticity, integrity, and confidentiality of electronic documents. Electronic records management systems must provide for secure. 

This chapter presents the basic requirements to access, review, approve, control, and maintain procedures. It also discusses the wide range of choices you have in selecting the level of control your plant needs and electronic document control methods that may he of assistance. Controlling the development, revision, and implementation of your procedures is an important part of your procedure management system (described in Chapter 3, How to Design an Operating and Maintenance Procedure Management System). 

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