PDA Technical Report No. 18, (TR 18) Validation of Computer-Related Systems (single user digital version)

Jan 1995
PDA Item Number

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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.

This Technical report was prepared by PDA Committee on Validation of Computer-Related Systems.

The report identifies factors to be considered and steps to be taken in selecting, installing, and validating Computer-Related Systems used in pharmaceutical GMP functions. It does not apply specifically to Medical Device or GLP applications, although the validation principles in those applications would be similar. the purpose is to provide information about validation concepts and to describe some of the practical documentation that may be used to demonstrate proper performance of Computer-Related Systems. Examples are included.

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Table of Contents

Table of Contents:

1. Introduction
2. Scope of Document
3. Validation Concepts
4. Validation Procedures
Appendix 1: Information to Consider for System Requirements
Appendix 2: Information to Consider for Vendor Evaluation
Appendix 3: Information to Consider for Computerized System Specifications
Appendix 4: Glossary
Appendix 5: Related Publications