The Importance of Validating LIMS and Laboratory Systems

Validation of computerised systems is a regulatory requirement for both GMP and GLP laboratories. Although computerised system validation (CSV) has been required for over 40 years, the approaches within laboratories can be an inflexible and one size fits all approach. The presentation will use risk-based approaches that meet regulatory compliance and leverage a supplier’s software development and testing to reduce the amount of validation required.

This will encompass the following:

• Mapping and redesign to simplify an analytical process prior to major project implementation e.g. LIMS or a networked CDS

• Using the maps to define user requirements: defining intended use

• Does the laboratory fit the LIMS or vice versa? The configuration versus customisation debate.

• How to leverage the supplier’s software development and testing to reduce in-house validation

• How to validate GAMP software category 3 computerised systems using a single integrated validation document

Learning Objectives: 

1. Review how process mapping can be used to streamline and simplify an analytical process and be an input to user requirements.

2. Demonstrate how to assess a supplier's software development processes to reduce your validation effort.

3. Identify when you can reduce validation of a computerized system to a single document.