PDA Technical Report No. 31, (TR 31) Validation and Qualification of Computerized Laboratory Data Acquisition Systems (single user digital version)

Jun 1999
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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 the PhRMA CSVWG and PDA Computer Related Systems - Laboratory Systems Task Group.

The purpose of this Report is to provide guidance to laboratory scientists, technicians and managers responsible for the implementation, testing, control and usage of Laboratory Data Acquisition Systems (LDAS) used within a GMP-, GLP-, or GCP-regulated environment. TR 31 specifically addresses computerized LDAS within a regulated environment, but is also applicable to systems considered critical to the operation of a company, department or function, regardless of the system`s regulatory impact.

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Table of Contents

Table of Contents:
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1. Objective
2. Scope
3. Overview of Validation Concepts
4. Fundamental LDAS Concepts and Attributes
5. Control Management Processes
6. Execution and other Administrative Issues
7. Other Issues
8. Examples of Laboratory System Validation
9. Glossary