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Resource Links

This compilation is in no way intended to be comprehensive.  Rather, it provides a relatively simple and easy way to drill down into the vast amount of information readily available on the Internet and locate the specific information you desire with a minimum of difficulty and wasted effort. 

The categories listed here are general in nature and in many cases overlap.  Further, most of the web sites listed also contain their own compilations of related links and we see no added value in duplicating them here. 

Inevitably there exist more useful sites so please feel free to Suggest A Link if you have a favorite. 

While these are links we find useful or interesting, their presence here in no way represents an endorsement of any organization, individual, or opinion. 


IT (Information Technology)
American National Standards Institute (ANSI)
Association for Computing Machinery (ACM)
Institute of Electrical and Electronic Engineers (IEEE)
National Institute of Standards and Technology (NIST) Information Technology Lab
 

Quality
Software Engineering Institute (SEI)
Capability Maturity Models (CMM)
Quality Digest
 

Regulatory

FDA (Food and Drug Administration)

Search Code of Federal Regulations (CFR) Title 21 Database
Comprehensive List of FDA Guidance Documents
FDA Warning Letters (483s) and Responses
Center for Drug Evaluation and Research (CDER) Mailing Lists
 

Agency Regulations

Title 21 Code of Federal Regulations (21 CFR Part 11)
Electronic Records; Electronic Signatures
21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule PDF version
(March 20, 1997)
Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application (August 2003)

Notice of withdrawal of all Part 11-related draft guidance documents:
Draft Guidance for Industry on ‘‘Part 11, Electronic Records, Electronic Signatures—Scope and Application;’’ Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide (February 25, 2003) http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf

Withdrawal of Compliance Policy Guide (CPG) 7153.17 and previously published part 11 draft guidance documents on validation, glossary of terms, time stamps, and maintenance of electronic records.
FR Notice of Availability--Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application PDF version  (February 19, 2003)

Draft Guidance for Industry on Part 11, Electronic Records, Electronic Signatures--Scope and Application PDF version  (February 14, 2003) http://www.fda.gov/cder/guidance/5505dft.pdf

Draft Guidance For Industry – Not For Implementation
Guidance For Industry 21 CFR Part 11 Electronic Records Electronic Signatures Glossary of Terms (August 29, 2001)

Additional documents, including background such as draft versions, side-by-side comparisons of draft vs. final versions, etc. is available at http://www.fda.gov/ora/compliance_ref/part11/ and http://www.fda.gov/cder/gmp/index.htm.

Guidance documents represent the Agency's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. 

CDER Guidance Document Search
http://www.fda.gov/cder/guidance/index.htm
 

ORA/FDA Google Appliance Search page
http://www.fda.gov/ora/orasrch.htm

Draft Guidance for Industry -- Not For Implementation
Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures
Maintenance of Electronic Records
resources/FDA Archiving Guidance.pdf (August 29, 2002)

General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Document issued on: January 11, 2002
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3901B1_03_Software Validation.pdf

International
EMEA (European Medicines Agency ): contains links to other European agencies