Tuesday, 8 May 2018

COMPUTER VALIDATION RELATED GUIDELINES IN PHARMACEUTICALS




COMPUTER VALIDATION RELATED GUIDELINES IN PHARMACEUTICALS



EU GMP Annex 11: Computerised Systems

FDA Guidance for Industry: Part 11, Electronic Records, Electronic Signatures: Scope and Application

FDA Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility

PIC/S Good Practices for Computerised Systems in Regulated "GXP" Environments (PI 011-3) Sept 2007

APIC - Computer validation Guide, December 2002

FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983

FDA Glossary of Computerized System and Software Development Terminology

Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs

Computerized systems used in clinical trials

FDA Guidance for Industry: Computerized Systems used in clinical trials-Draft

APIC - Technical Change Control Guideline 2004 (October 2004)

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations

“Computer Crossmatch” (Computerized Analysis of the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)

FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE

Eudralex Volume 10 Annex III TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS Computer Systems

Eudralex Volume 10 Annex V GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Phase I Units

FDA COMPLIANCE POLICY GUIDE Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software (CPG 7132a.17)

FDA COMPLIANCE POLICY GUIDE Sec. 425.200 Computerized Drug Processing; Vendor Responsibility (CPG 7132a.12)

FDA COMPLIANCE POLICY GUIDE Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs (CPG 7132a.15)

FDA COMPLIANCE POLICY GUIDE Sec. 425.400 Computerized Drug Processing; Input/Output Checking (CPG 7132a.07)

FDA COMPLIANCE POLICY GUIDE Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records (CPG 7132a.08)

FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility






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