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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
(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all Part 11-related draft guidance documents:
Draft Guidance for Industry on ‘‘Part 11,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and Application;’’ Availability of Draft Guidance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Policy Guide (CPG) 7153.17 and previously published part 11 draft guidance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Availability--Draft Guidance for Industry on Part 11, Electronic Records,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
(February 19, 2003)
Draft Guidance for
Industry on Part 11, Electronic Records, Electronic Signatures--Scope and
Application
(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
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