Janet Gough's Managing the Documentation Maze: Answers to Questions You PDF
By Janet Gough
The obtainable, easy-to-follow consultant that demystifies documentation management
by way of receiving documentation to substantiate solid technology, U.S. and overseas regulators position excessive calls for at the healthcare undefined. hence, businesses constructing and production healing items needs to enforce a technique that enables them to correctly deal with their documents and files, considering that they need to agree to rigorous criteria and be on hand for regulatory evaluation or inspection at a moment’s observe.
Written in a trouble-free Q&A kind for fast reference, Managing the Documentation Maze presents solutions to 750 questions the authors come across often of their roles as specialists and running shoes. in basic terms, this convenient consultant breaks down the most important elements that facilitate profitable rfile administration, and indicates why it has to be a center self-discipline within the with details on:
- Compliance with rules in pharmaceutical, organic, and machine list retaining
- Electronic structures, hybrid platforms, and the complete scope of documentation that businesses needs to deal with
- How to put in writing and edit files that meet regulatory compliance
- Making the transition to an digital approach, together with the way to validate and record the method
a person liable for coping with files within the future health box will locate this e-book to be a depended on accomplice in unraveling the bureaucratic net of bewilderment, whereas it initiates a plan on how you can positioned an efficient, lasting procedure in place—one that may face up to any kind of scrutiny. Content:
Chapter 1 knowing the rules (pages 1–28):
Chapter 2 humans, procedure, and Documentation (pages 29–45):
Chapter three rules of rfile administration (pages 47–68):
Chapter four determining to head digital and discovering a seller (pages 69–96):
Chapter five Making the Transition from Hybrid to tested E?System (pages 97–119):
Chapter 6 half eleven Compliance (pages 121–140):
Chapter 7 normal working tactics (pages 141–159):
Chapter eight Nonclinical files (pages 161–171):
Chapter nine medical and Submission files (pages 173–202):
Chapter 10 Consistency and clarity in files (pages 203–221):
Chapter eleven holding the process (pages 223–237):
Chapter 12 holding Inspection Readiness (pages 239–253):
Chapter thirteen assets (pages 255–258):
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Extra info for Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask
How do source data support other documentation? 25. Do source data require controls? 26. What category of documentation do laboratory notebooks fall into? 27. What are “backbone” or “skeleton” documents? 28. What’s the difference between a procedure and a manual? 29. Should drug manufacturers have quality manuals? 30. If a company creates a “work aid” to augment an SOP, does it require controls? 31. Can a company create a document that is not legally binding? 32. Do companies need to keep documentation on activities that are not directly related to a product?
Managing the Documentation Maze, By Janet Gough and David Nettleton Copyright © 2010 John Wiley & Sons, Inc. 47 48 MANAGING THE DOCUMENTATION MAZE 13. In a hybrid system, which copy is the official, paper or scanned? 14. If using a hybrid system, how does the handwritten signature link to the electronic record? 15. If we use electronic signatures, is compliance with Part 11 mandatory? 16. Are electronic signatures always necessary for the creation of electronic records? 17. Do e-records and e-signatures require the same controls?
12. What exactly is a hybrid system? Managing the Documentation Maze, By Janet Gough and David Nettleton Copyright © 2010 John Wiley & Sons, Inc. 47 48 MANAGING THE DOCUMENTATION MAZE 13. In a hybrid system, which copy is the official, paper or scanned? 14. If using a hybrid system, how does the handwritten signature link to the electronic record? 15. If we use electronic signatures, is compliance with Part 11 mandatory? 16. Are electronic signatures always necessary for the creation of electronic records?