A common question I get from my clients is ‘what documentation/SOPs are necessary to properly implement a regulated computer system?’ I recommend a list found in Appendix A of Guidance for Industry Computerized Systems Used in Clinical Investigations FDA 2007 Guidance Document
. This list is defined for Clinical sites and related activities as stated in the scope of the document. However, after reviewing the list provided in Appendix A, I believe that it is applicable to other regulated systems beyond the scope clinical systems. This post is recommended for anyone who plans on implementing a regulated computer system.
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