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Re: Document Control/Quality ManagementI was recently charged with the task of locating "something that will help The first question I would ask, and I'd want the answer to be official and in writing: Which SPECIFIC regulations or standards for document control are we required to comply with now, and what is our best guess about what we will be required to comply with in the foreseeable future? (If your firm operates in a regulated environment, there's almost certainly someone designated as the compliance officer; ask this person.) Develop your requirements list based on this information, and use that list as your basis for evaluation of methods, processes and products to meet your document control needs. Make sure that your compliance officer and your management signs off on your requirements list and keep them in the loop every step of the way as you do your research. Let's assume that your firm develops software, for instance. Maybe "ISO" means some or all of the following: ISO 9000/9001 quality standards. Or ISO/IEC 12207 for software development lifecycles? ISO/IEC 15288 for systems engineering documentation? ISO/IEC 15910 for user documentation? Etc. Or, since you mention FDA regulations, you're almost certainly required to comply with 21 CFR Part 11, and probably others. (Does your firm make medical devices? See ISO 13485:2003...) - bc, doesn't work in highly regulated environments much lately but remembers it well -- Barry Campbell -- <barry -at- campbell-online -dot- com> Blog: http://campbell-online.com ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ WebWorks ePublisher Pro for Word features support for every major Help format plus PDF, HTML and more. Flexible, precise, and efficient content delivery. Try it today! http://www.webworks.com/techwr-l Easily create HTML or Microsoft Word content and convert to any popular Help file format or printed documentation. Learn more at http://www.DocToHelp.com/TechwrlList --- You are currently subscribed to TECHWR-L as archive -at- infoinfocus -dot- com -dot- To unsubscribe send a blank email to techwr-l-unsubscribe -at- lists -dot- techwr-l -dot- com or visit http://lists.techwr-l.com/mailman/options/techwr-l/archive%40infoinfocus.com To subscribe, send a blank email to techwr-l-join -at- lists -dot- techwr-l -dot- com Send administrative questions to admin -at- techwr-l -dot- com -dot- Visit http://www.techwr-l.com/techwhirl/ for more resources and info. References:
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