1. ISO 90003:2004, Software engineering - Guidelines for the application of ISO 9001:2000 to computer software. Available at http://www.iso.org
2. ISO 12207:1995, Information Technology - Software Life Cycle Processes. Available at http://www.iso.org
3. 21 CFR Part 11, Electronic Records; Electronic Signatures. Available at http://www.fda.gov/oc/gcp/regulations.html
4. FDA: Guidance for Industry: Computerized systems used in Clinical Trials, April 1999. Available at http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf
5. The Good Automated Manufacturing Practice (GAMP4) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. December 2001. Information on GAMP4 available at http://www.ispe.org/gamp