FDA 12 CFR 11 in a Nutshell By Tim Donaldson, Marketing Manager - Iconics Inc Downloadable copies of 21 CFR Part 11 from FDA site. 21 CFR Part 11 Resource Home Page compiled by John L. Boettcher. This is a very useful site - simple and to the point. It includes details of events to do with the topic. Implementation in Analytical Laboratories Electronic Records; Electronic Signatures some interesting information with comparisons. 21 CFR Part 11 Working Group Resource Center In March 1997, CENSA established the first Pharmaceutical Industry Working Group to provide guidance toindustry and the FDA about the potential impact of the FDA's Rule, 21 CFR Part 11: Electronic Signatures; Electronic Records. Good Practice and Compliance for Electronic Records and Signatures is a publication from ISPE(the International Society for Pharmaceutical Engineering). Life SciencesInfo.com a leading resource for scientific, technological and business information from IBC Life Sciences especially in the area of pharmaceutical standards like CFR Part 11. IBC Life Sciences has been supporting and supplying the life science industry with specialized information through its conferences and publishing products since 1987. Noblitt & Rueland is a leading medical device consulting firm specializing in technical FDA & ISO regulatory issues including Quality Systems, Design Control, Software, electronic recordkeeping & regulatory consulting for FDA & Internationally regulated medical industries. They have papers and publications which can be helpful in this area. Roker provides a series of papers which help in getting ready for FDA approval. "Will your calibration system stand up to the scrutiny of an FDA or IMB audit?"