0 Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations

Documentation Basics, second edition, includes everything you need to know about establishing a company-wide documentation system that meets GMP and QSR requirements. Documentation Basics, second edition, continues to provide - like the first edition - a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, logbooks, etc. Newly added features to the 2nd Edition are basic documentation practices for specific functional areas of operations such as Maintenance, Material Handling, Validation, Quality Control, Quality Assurance, and Production. In medical manufacturing environments, a sound, sensible and simple documentation system is the foundation of GMP. Using sample documents and simple, step-by-step instructions, this book outlines the major components of a documentation system, demonstrates how they interact and provides examples of their design, format and content. This comprehensive, hands-on guide will enable you to design an effective documentation system that ensures quality standards are met, minimizes errors, reduces downtime and serves as a training tool for line workers and administrators.

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