Quality Assurance in Clinical Research
PMK operates according to the following international guidelines:
• CPMP/ICH/135/95 (Topic E 6: ICH Guideline for GCP)

• CPMP/ICH/291/95 (Topic E 8: General Considerations for Clinical Trials)

• CPMP/ICH/377/95 (Topic E 2 A: Clinical Safety Data Management:

Definitions and Standards for Expedited Reporting)

• CPMP/ICH/287/95 (Topic E 2 B: Clinical Safety Data Management for

Expedited Reporting: Data Elements for Transmission of Individual Case Safe Reports)

• CPMP/ICH/363/96 (Topic E 9: Statistical Principles for Clinical Trials)

• III/3630/92-EN (CPMP-Note for Guidance: Biostatistical methodology in

clinical trials in applications for marketing authorisations for medicinal

products)

• CPMP/ICH/137/95 (Topic E 3: Structure and Content of Clinical Study Reports)

Computer System Validation
FDA Medical Device Software Validation, Guidance for Industry: General

Principles of Software Validation, 1997 (Draft)

FDA, Guidance for Industry: Computerized Systems Used in Clinical Trials,1999

FDA: Title 21 CFR Part 11, 1997

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application, DRAFT GUIDANCE, 20. FEB 2003

ACDM/PSI Working Party, Computer Systems Validation in Clinical Research. A practical Guide, Macclesfield, Cheshire (1998)


ANSI/ISO/ASQ Q9000-3-1997: Quality management and quality assurance

standards - Part 3: Guidelines for the application of ANSI/ISO/ASQC Q

9001-1994 to the development, supply, installation and maintenance of

computer software (www.asq.org)

FDA: Glossary of Computerized Systems and Software Development

Terminology (www.fda.gov/ora/inspect_ref/igs/gloss.html)

ICH Glossary: ICH-M2, ESTRI Ver 2.1, 07 DEC 1997

GAMP - Part 11 Special Interest Group - Complying with

21 CFR Part 11 - Final Draft - 1 SEP 2000

The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) (http://www.ispe.org/gamp/)

Guidance for Industry: Bioanalytical Method Validation, May 2001

Final Version of Annex 15 to the EU Guide to GMP Juli 2001

Recommendation on Validation Master Plan - Installation and Operational Qualification – Non-Sterile Process Validation – Cleaning Validation/© PIC/S August 2001

PDA Suggested Revision, Annex 15 - Validation Principles, 25 FEB 2000


Institute of Electrical and Electronic Engineers (IEEE), USA, if appropriate:

• IEEE 610.12 (1990) Glossary of Software Engineering Technology

• IEEE 730 (1989) Standard for Software Quality Assurance Plans

• IEEE 828 (1990) Standard for Software Configuration Management Plans

• IEEE 829 (1993) Standard for Software Test Documentation

• IEEE 830 (1990) Recommended Practice for Software Requirements Specification

• IEEE 983 (1986) Guide to Software Quality Assurance Planning

• IEEE 1012 (1992) Standards for Software Verification and Validation Plans

• IEEE 1016 (1987) Recommended Practice for Software Design Descriptions

• IEEE 1016.1 (1993) Guide to Software Design Descriptions

• IEEE 1028 (1996) Standard for Software Review and Audits

• IEEE 1042 (1987) Guide to Software Configuration Management

• IEEE 1059 (1993) Standards for Verification and Validation Plans

• IEEE 1063 (1987) Standard for Software User Documentation

• IEEE 1074 (1991) Standard for Developing Software Life Cycle Processes

• IEEE 1219 (1992) Standard for Software Maintenance