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Validation of a customized LIMS

C Bund¹, G W Heinemann, B Jäger

¹Novartis Pharma AG, Basel, Switzerland. christian.bund@pharma. novartis.com

Pharmaceutica Acta Helvetiae

|April 29, 1998

Summary

Customized Laboratory Information Management Systems (LIMS) offer tailored solutions for unique organizational needs. This paper details the validation process for a customized analytical LIMS, ensuring regulatory compliance and intended use.

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Area of Science:

Laboratory Science
Information Management Systems
Analytical Chemistry

Background:

Customized Laboratory Information Management Systems (LIMS) are increasingly sought after due to diverse organizational R&D and production requirements.
While core LIMS software is often commercially available, customized modules present unique validation challenges.
Validation of complex computerized systems is essential for regulatory compliance and to guarantee intended use.

Purpose of the Study:

To provide an example of the validation process for a customized analytical LIMS.
To highlight critical elements in the validation of customized LIMS, particularly individual application modules.
To emphasize the importance of regulatory requirements in system validation.

Main Methods:

Focus on the validation of customized analytical LIMS, including supplier audits for programmed modules.
Review of user requirement specifications and acceptance testing of software modules.
Consideration of hardware suitability and principal processing routines as key validation components.

Main Results:

The validation process for customized LIMS involves critical assessment of individual application modules.
Supplier audits, user specifications, and acceptance testing are crucial for validating customized LIMS.
Thorough validation ensures the customized LIMS meets intended use and regulatory standards.

Conclusions:

The validation of customized analytical LIMS is a critical process for ensuring data integrity and regulatory compliance.
Key aspects of validation include supplier audits, user requirement specifications, and acceptance testing of customized modules.
Effective validation guarantees that customized LIMS function as intended within specific organizational contexts.

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