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Validation of computer systems: practical testing of a standard LIMS
D Friedli1, W Kappeler, S Zimmermann
1Spirig AG, Froschacker, Egerkingen, Switerzerland. szimmerm@cilch. jnj.com
Pharmaceutica Acta Helvetiae
|April 29, 1998
Summary
This paper discusses validation testing for standard laboratory information management systems (LIMS) in pharmaceutical settings. It outlines critical test procedures for LIMS verification to meet Good Manufacturing Practice (GMP) requirements.
Area of Science:
- Pharmaceutical Science
- Computer Science
- Quality Assurance
Background:
- Computer systems for data handling are increasingly used in the pharmaceutical industry.
- Standard laboratory information management systems (LIMS) facilitate data management and support Good Manufacturing Practice (GMP) compliance.
- Validation of computer systems in GMP areas is mandatory.
Purpose of the Study:
- To discuss suitable test procedures for the verification step of standard LIMS validation.
- To address the user's responsibility in the LIMS validation process.
Main Methods:
- Focus on verification procedures for critical LIMS functions.
- Review of testing strategies for commercially available LIMS software.
Main Results:
- Identified critical functions within standard LIMS requiring specific verification.
- Proposed test procedures applicable to the LIMS verification phase.
Conclusions:
- Users must perform comprehensive validation for standard LIMS, even with supplier validation.
- Effective test procedures are crucial for successful LIMS verification in GMP environments.