By Janet Gough
The obtainable, easy-to-follow advisor that demystifies documentation managementWhen it involves receiving documentation to substantiate reliable technological know-how, U.S. and overseas regulators position excessive calls for at the healthcare undefined. accordingly, businesses constructing and production healing items needs to enforce a technique that permits them to correctly deal with their files and files, in view that they have to conform to rigorous criteria and be to be had for regulatory assessment or inspection at a moment’s notice.Written in a elementary Q&A variety for speedy reference, coping with the Documentation Maze offers solutions to 750 questions the authors stumble upon often of their roles as experts and running shoes. simply, this useful advisor breaks down the foremost elements that facilitate winning rfile administration, and indicates why it should be a middle self-discipline within the with info on:Compliance with laws in pharmaceutical, organic, and equipment list keepingElectronic platforms, hybrid platforms, and the whole scope of documentation that businesses needs to manageHow to jot down and edit files that meet regulatory complianceMaking the transition to an digital process, together with easy methods to validate and rfile the processAnyone chargeable for dealing with files within the overall healthiness box will locate this booklet to be a depended on companion in unraveling the bureaucratic net of misunderstanding, whereas it initiates a plan on find out how to placed an efficient, lasting method in place—one that would face up to any form of scrutiny.
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Additional resources for Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask
What is the purpose of source data? 24. 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?
Is there an ofﬁcial guidance document that identiﬁes what documents require controls? 20. What types of documents do companies generate? 21. What kinds of reports do companies generate? 22. What are source data? 23. What is the purpose of source data? 24. 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?
It is best to control white papers and document how they evolve into standard documents if they do. 53. What Are Submission Documents? Submission, or regulatory, documents go to an audience outside the company—the regulators. These documents sum up development activities for products in the 42 MANAGING THE DOCUMENTATION MAZE clinic. These documents include Investigational New Drug Applications (INDAs), Investigational Device Exemptions (IDEs), Clinical Trial Authorizations (CTAs), and dossiers for market approval.
Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask by Janet Gough