Computer Systems Validation & Regulatory Links

Regulatory Sites

1987 Preamble to GLPs

21 CFR Part 11 - Electronic Records; Electronic Signatures

CBER Home Page: Center for Biologics Evaluation and Research

CDER Home Page: Center for Drug Evaluation and Research

CDRH Home Page: Center for Devices and Radiological Health

Code Of Federal Regulations Searchable database of federal regulations

EMEA Welcome page

EPA Home Page

EPA GLPs (40 CFR Part 160)

EPA Q&A on GLPs

FDA Home Page

FDA Guidance Documents

FDA GLPs (21 CFR Part 58)(1987)

GALPs: EPA’s Good Automated Laboratory Practices

IFPMA International Federation of Pharmaceutical Manufacturers Associations (IFPMA)

ICH International Conference on Harmonization

Medicines Control Agency

OECD Organization for Economic Co-Operation and Development

USP (US Pharmacopeia)

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Professional Associations

American Association for Analytical Excellence

American Society of Quality

GAMP: Good Automate Manufacturing Practices

www.ieee.org

Institute for Validation Technology

ISA-The Instrumentation, Systems, and Automation Society

ISPE Home Page: International Society for Pharmaceutical Engineering

Mid-Atlantic Regional Society of QA

PDA Home Page: the Parenteral Drug Association

PhRMA Home Page: Pharmaceutical Research and Manufacturers of America

Project Management Institute

Regulatory Affairs Professional Society

Safety Pharmacology Society

Society of Quality Assurance

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Pharmaceutical Resources

21 CFR Part 11 Resources

21CFRPart11. com

American National Standards Institute

American Standards for Testing and Materials

Association for the Advancement of Medical Instrumentation

Bio Online: Biotechnology & Pharmaceutical Sciences Information Services

BioPharm Magazine

Biotechnology Industry Organization

ComputerValidation.Com

LabCompliance.Com

MedMarket

Non-Compliance Warning Letters

Pharmaceutical Online

PharmWeb

www.pharmaportal.com.

Pharmaceutical Technology Magazine

Software CPR

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