Links

We hope you find these links useful. Please let us know if there are additional sites that should be added to this reference list.

Regulatory Sites     

U.S. Food and Drug Administration (FDA) 

U.S. Environmental Protection Agency (EPA)

Health Canada

Medicines and Healthcare products Regulatory Agency (MHRA) UK

European Medicines Agency (EMA)

Regulations, References, and Guidance Documents     

21 CFR Part 11 - Electronic Records; Electronic Signatures

21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies

21 CFR Part 203 - Prescription Drug Marketing Act

21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals

21 CFR Part 820 - Medical Device Quality System Regulation

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

FDA Guidance Documents

Frequently requested ORA documents and FDA 483s

Warning Letters

Standards and Industry/Professional Associations

American National Standards Institute (ANSI)

American Society for Quality (ASQ)

Drug Information Association (DIA)

Good Automated Manufacturing Practice (GAMP) Publications

Institute of Electrical and Electronic Engineers (IEEE)

International Conference on Harmonisation (ICH) Guidelines

International Society for Pharmaceutical Engineering (ISPE)

International Organization for Standardization (ISO)

National Institute of Standards and Technology (NIST) Information
Technology Lab

Parenteral Drug Association (PDA)

Pharmaceutical Research and Manufacturers of America (PhRMA)

Society of Quality Assurance (SQA)

Society for Software Quality (SSQ)

Software Engineering Institute (SEI)

Online Resources/References

RegSource (Regulatory Information)

21 CFR Part 11.com