Skipper explains the requirements for complying with the US Food and Drug Administration's regulation and ISO standard 9001 and 13485 for documented information controls, and presents a methodology for compliance. Her topics include document management versus document control, manual document control systems verses electronic document control systems, a process-based approach, the organization of controlled documents, incorporating document control objectives and requirements into the document control procedural set, writing the document control policy, and writing the document control work instructions. Annotation ©2016 Ringgold, Inc., Portland, OR (protoview.com)
