CSols provides industry leading solutions that enable you to be 21CFR11 compliant. Here you will find a comprehensive list of links to other 21CFR11 web resources.

information for companies regulated by FDA

FDA Warning Letters - General Searches

FDA 21 CFR Part 11 - E-Record / E-Sig Rule - Scope & Application - Draft Guidance February 2003

FDA 21 CFR Part 11 - E-Record / E-Sig Rule - Final Rule

21CFR Part11.COM - is a Waters Informatics sponsored web site that provides access to information on the rule and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators. On this site you will find the latest conference, meeting and seminar information as well as links to vendors and consultants who can help the pharmaceutical community with issues of compliance with regulations and productivity.

Links to other Regulatory Affairs Websites

australia

Therapeutic Goods Administration

Pharmaceutical Inspection Co-operation Scheme (PICS)

canada

Canadian Health Products and Food Branch

CENSA
The Collaborative Electronic Notebook Systems Association (CENSA) is an international industry association, focused on driving the state of the art for electronic record keeping systems and collaborative technologies wherever they are used.

GAMP
The GAMP Online Forum exists to promote the understanding of the regulation and use of computer and control systems within healthcare industries.

european

European Agency for the Evaluation of Medicinal Products

International Conference on Harmonisation (ICH) Home Page

Pharmacopoeias

European Pharmacopoeia

US Pharmacopoeia

UK

DEFRA
The functions of the Ministry of Agriculture, Fisheries and Food have been taken over by the Department for Environment, Food and Rural Affairs.

UK Drinking Water Regulations

Medicines Control Agency

Medical Devices Agency

MAFF (see DEFRA)

UK Statutory Instruments

Veterinary Medicines Directorate (MAFF)

National Institute for Biological Standards and Control

USA FDA

FDA - Centre for Biologics Evaluation and Research

FDA - Centre for Drug Evaluation and Research

FDA - Codes of Federal Regulations

FDA - Inspectional References: Index

FDA - Inspection Guides

FDA - Guidance Documents: Index

USA environmental

US EPA

EPA Libraries

World Health Organisation (WHO)

WHO

If you know any other useful website links that you would like to see on this resource page then please email sales@csols.com with the link. Thank you.