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

Published
Jun 1999
Pages
12
PDA Item Number
43235

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

Format
PDF Single user
Member Price
$50.00
Nonmember Price
$100.00
Government Price
$50.00

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.

Available to download
Format: PDF (1 file - 1.89 MB)

Click here for the digital downloading instruction and Terms of Usage.

To order paper ship version, please click here.

*To purchase licensing, please contact PDA at [email protected].

Table of Contents

Table of Contents:
Click here to download >>>Table of Contents

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