Guidance for industry: 21 CFR part 11, electronic records, electronic signatures, validation (Paperback)

Original publisher: Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs: Center for Biologics Evaluation and Research: Center for Drug Evaluation and Research: Center for Devices and Radiological Health: Center for Food Safety and Applied Nutrition: Center for Veterinary Medicine, [2001] OCLC Number: (OCoLC)427904766 Subject: Electronic records -- Government policy -- United States. Excerpt: ... Draft Guidance for Industry-Not For Implementation other customizations that they prepare. End users should also be able to validate off-the-shelf software by performing all of the following: 6.1.1 End User Requirements Specifications End users should document their requirements specifications relative to part 11 requirements and other factors, as discussed above. The end user's requirements specifications may be different from the developer's specifications. If possible, the end user should obtain a copy of the developer's requirements specifications for comparison. 6.1.2 Software Structural Integrity Where source code is not available for examination, end users should infer the adequacy of software structural integrity by doing all of the following: • Conducting research into the program's use history. This research should include: ( 1 ) Identifying known program limitations; ( 2 ) evaluating other end user experiences; and, ( 3 ) identifying known software problems and their resolution; and • Evaluating the supplier's software development activities to determine its conformance to contemporary standards. The evaluation should preferably be derived from a reliable audit of the software developer, performed by the end user's organization or a trusted and competent third party. 12