U.S. FDA Regulatory References

• 21 CFR Part 11:  www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf
• Guidance for Industry on Part 11, Electronic Records, Electronic Signatures – Scope and Application, 2003: http://www.fda.gov/cder/guidance/5667fnl.pdf
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002: www.fda.gov/cdrh/comp/guidance/938.html
• Guidance for Industry: Computerized Systems Used in Clinical Trials, 1999: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf
• A Risk-Based Approach to Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A Progress Report: www.fda.gov/cder/gmp/index.htm
• Electronic Submissions (CDER): http://www.fda.gov/cder/regulatory/ersr/default.htm
• Guidance for Industry: Providing Regulatory Submissions in Electronic Format – General Considerations, 1999.  http://www.fda.gov/cder/guidance/2867fnl.pdf
• Providing Regulatory Submissions in Electronic Format — Content of Labeling; Draft Guidance, 2004. http://www.fda.gov/cder/guidance/6028dft.pdf
• Electronic Common Technical Document: www.fda.gov/cder/regulatory/ersr/ectd.htm

Other Regulatory & Standards References

ICH Guideline for Good Clinical Practice: www.ich.org/MediaServer.jser?@_ID=482&@_MODE=GLB

The Rules Governing Medicinal Products in the European Union, VOLUME 4: Medicinal products for human and veterinary use : Good manufacturing practices, Annex 11: Computerised Systems http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/anx11en.pdf

Good Practices for Computerized Systems in Regulated “GXP” Environments, PIC/S Guidance, 2003  http://www.picscheme.org/docs/pdf/PI 011-1 Recommendation on Computerised Systems.pdf

Health Insurance Portability and Accountability Act of 1996: http://www.hhs.gov/ocr/hipaa

Sarbanes-Oxley Act of 2002: http//www.sarbanes-oxley-forum.com

COSO framework: www.coso.org/

NIST Special Publication SP800-30: Risk Management Guide for Information Technology Systems, 2002 http://csrc.nist.gov/publications/nistpubs/800-30/sp800-30.pdf

ISO 14971:2000 – Medical devices - Application of risk management to medical devices, 2000. http://www.iso.org

NIST Special Publication SP 800-26: Security Self-Assessment Guide for Information Technology Systems, 2001 http://csrc.nist.gov/publications/nistpubs/800-26/sp800-26.pdf

ISO/IEC 17799:2000 (BS 7799:2000) Information technology – Code of practice for information security management (ISO/IEC, 2000) http://www.ansi.org/

The Good Automated Manufacturing Practice (GAMP) Guide for Validation ofAutomated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) www.ispe.org/gamp

EPA: Primer on Environmental Public Health Information Activities http://www.epa.gov/oei/imwg/pdf/env_health_primer_0506.pdf

No. 10 in OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring: The Application of the Principles of GLP to Computerised Systems, 1995 www.oecd.org/LongAbstract/0,2546,en_2649_201185_1914514_1_1_1_1,00.html

LEGAL CONSIDERATIONS IN DESIGNING AND IMPLEMENTING ELECTRONIC PROCESSES: A GUIDE FOR FEDERAL AGENCIES, U.S. Department of Justice, 2000. http://www.usdoj.gov/criminal/cybercrime/eprocess.pdf

Records Management Guidance for Agencies Implementing Electronic Signature Technologies, National Archives and Records Administration, 2000. http://www.archives.gov/records_management/pdf/electronic_signiture_technology.pdf