Regulations and Guidelines
Showing 113–128 of 133 results
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Japan MHLW Ordinance 136 2004 Quality Assurance for Drugs, Cosmetics, and Medical Devices, 9/04
Japan’s 2004 Ministerial Ordinance on Standards for Quality Assurance for drugs, quasi-drugs, cosmetics, and medical devices. Records requirements throughout.
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FDA Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach, 9/04
September, 2004 report on the FDA’s modernization programs. Contains an update on 21 CFR Part 11 approach.
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FDA Guidance: Part 11, Electronic Records; Electronic Signatures – Scope and Application, 8/03
August, 2003 guidance on 21 CFR Part 11 scope of application, enforcement focus areas, and a risk based compliance approach.
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FDA Guide to Inspection of Computerized Systems in the Food Processing Industry, 4/03
ORA guidance to inspectors regarding how to audit system hardware, software, networks, validation, maintenance, and procedures.
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FDA Glossary of Computerized System and Software Development Terminology, 4/03
Reference list of computer and software terms with definitions from IEEE, ANSI, ISO, NIST, NBS, and various other sources
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FDA Guidance: General Principles of Software Validation, 1/02
January, 2002 FDA guidance on how to validate software used in medical devices, process equipment software, and quality system software.
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FDA Draft Guidance (Withdrawn): Premarket Notification Submissions for Automated Testing Instruments Used In Blood Establishments, 8/01
Withdrawn 2001 CBER draft guidance regarding automated instrument functional requirements, design, development, hazard analyses, validation, change control, etc.
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Eudralex V4 Annex 18: GMP Guidelines for Active Pharmaceutical Ingredients, 7/01
GMP for API manufacturers. See sections 2.22.9, 2.23.8, 5.4, 6.12, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.
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ICH Q7: GMP Guide for Active Pharmaceutical Ingredients, 11/00
GMP for API manufacturers. See sections 2.22 (10), 2.23 (8), 5.4, 6.1, 12.1, 12.2, 12.3, 12.6, 13.11, and 13.13 for specific computer and validation requirements.ﾠ
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FDA Guidance: Off-The-Shelf Software Use in Medical Devices, 9/99
September, 1999 CDRH guidance regarding OTS software in device documentation needs, hazard analyses, hazard mitigation, and 510(k), IDE, and PMA issues.
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FDA 21 CFR 11: Electronic Records; Electronic Signatures, 3/97
The FDA regulation on electronic records and electronic signatures.
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FDA 21 CFR 11: Electronic Records; Electronic Signatures and Preamble, 3/97
FDA Preamble and regulation on electronic records and electronic signatures.
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ICH E6(R1): Good Clinical Practice, 1/97
1997 ICH GCP for pharmaceuticals. Includes audit trails, system validation, system SOPs, and back-ups.
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OECD The Application of the Principles of GLP to Computerised Systems, 2/95
1995 version of the OECD’s standards for laboratory computer systems used in clinical studies destined for regulatory submissions.
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FDA Draft Guidance (Withdrawn): Validation of Blood Establishment Computer Systems, 9/93
Withdrawn 1993 CBER draft guideline for blood establishment system validation testing, change control, security, audit trails, SOPs, training, maintenance, and audits.
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FDA Computerized Devices/Processes Guidance, 5/92
1992 FDA guidance 21 CFR 820 cGMP for manufacturing computerized medical devices, controlling computerized manufacturing processes, and quality systems.
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