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GAMP
Good Automated Manufacturing Pracice

 

Training materials

  Title  
Workshop:
Validation of computerized systems
August 10, 2015
 

Workshop:
Validation of computerized systems
November 25, 2011

Presentation Outline
«
Validation of computerized systems»

 

Standards and recommendations

  Title
Data Integrity Definitions and Guidance for Industry March 2015
Good Automated Manufacturing Practice
Pharmaceutical Industry Supplier Guide for Validation of Automated Systems
ANSI/ISA–88.01
Batch Control
Part 1: Models and Terminology
FDA REGULATED INDUSTRIES – VALIDATION CAPABILITIES OVERVIEW
GAMP/JETT AGENDA
Guidance for Industry 21 CFR Part 11;
Electronic Records; Electronic Signatures
Validation

 

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