21 Cfr Part 11

Author : Orlando López
Publisher : CRC Press
ISBN 13 : 1135488754
Total Pages : 287 pages
Book Rating : 4.58/5 ( download)

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Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places

Author : Janet Gough
Publisher : John Wiley & Sons
ISBN 13 : 0470597496
Total Pages : 486 pages
Book Rating : 4.91/5 ( download)

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Download or read book Managing the Documentation Maze written by Janet Gough and published by John Wiley & Sons. This book was released on 2010-03-16 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.

Author : Fda
Publisher : Gmp Publications
ISBN 13 : 9781933734002
Total Pages : 24 pages
Book Rating : 4.00/5 ( download)

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Download or read book 21 CFR Part 11 Pocket Guide written by Fda and published by Gmp Publications. This book was released on 2005-01-30 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: 21 CFR Part 11 - Electronic Records/Signatures (ERES) w/Scope and Applications

Author :
Publisher :
ISBN 13 :
Total Pages : 6 pages
Book Rating : 4.30/5 ( download)

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Download or read book Guidance for Industry written by and published by . This book was released on 2001 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Gladys Q. Ramey
Publisher :
ISBN 13 :
Total Pages : 112 pages
Book Rating : 4.78/5 ( download)

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Download or read book Document Drafting Handbook written by Gladys Q. Ramey and published by . This book was released on 1991 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author :
Publisher :
ISBN 13 : 9781935131212
Total Pages : pages
Book Rating : 4.14/5 ( download)

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Download or read book Title 21 CFR Part 11, 110 and 111 GMPs for Food and Dietary Supplement written by and published by . This book was released on 2010-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 21 CFR Parts 11, 110 & 111-Food & Supplement GMPs - ERES, Current Good Manufacturing, Packaging, holding of human food, Labeling or holding operations for dietary supplements

Author : Orlando López
Publisher : CRC Press
ISBN 13 : 9780849322433
Total Pages : 243 pages
Book Rating : 4.3X/5 ( download)

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Download or read book 21 CFR written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

Author : Carol I. Matthews
Publisher : SAS Institute
ISBN 13 : 1599941287
Total Pages : 229 pages
Book Rating : 4.88/5 ( download)

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Download or read book Validating Clinical Trial Data Reporting with SAS written by Carol I. Matthews and published by SAS Institute. This book was released on 2008 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.

Author : United States
Publisher :
ISBN 13 :
Total Pages : 1508 pages
Book Rating : 4.63/5 ( download)

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Download or read book United States Code written by United States and published by . This book was released on 1952 with total page 1508 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Gisela Leon
Publisher :
ISBN 13 : 9781532338328
Total Pages : pages
Book Rating : 4.25/5 ( download)

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Download or read book Food Labeling Handbook written by Gisela Leon and published by . This book was released on 2017-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: