VALIDATION

Services / Validation

Regulated industries will require a level of validation to be completed for your LIMS. Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes [1]. For most laboratories, a CDS (Chromatography Data system) or a LIMS is the first software validation project undertaken. Equipment qualification is often a more familiar practice to laboratory personnel, and we have summarised below the similarities between the commonly known 4Q model for equipment qualification and software validation.

 

4Q Term

Description

Validation Activity

Design Qualification

Documented verification that the proposed design is suitable for the intended purpose.

Does the system have the features required for its intended use?

Design Review

Installation Qualification

Documented verification that a system is installed in accordance with written and pre-approved procedures or specifications.

Has the system been installed properly, and can it power on?

Testing or other verification activity that the installation or configuration of both the software and hardware are correct.

Can be documented within Technical Installation Plans/Reports and/or Configuration Management Plans

Operational Qualification

Documented verification that a system operates to written and pre-approved specifications within the designated operating ranges.

Can you run a sample through the system? Does it accurately analyse the sample?

Testing of the system against user requirements to demonstrate correct operation of functionality that supports the business process.

Documented within Test Plan/Cases/Reports

Performance Qualification

Documented verification that a system can perform the activities of the process it is required to perform per written and pre-approved specifications within the scope of the business process and operating environment.

Can the system continually analyse samples accurately?

Testing of the system to demonstrate that fitness for intended use and allow acceptance of the system against specified requirements.

Documented as part of the Test Plan/Cases and Report typically post go-live as an initial monitoring period of use.

 

For a full guideline list of validation activities for a typical LIMS implementation within a GxP environment click here to download our PDF.

Broughton Software offers Validation Services as part of the implementation process.  A dedicated and GxP experienced project manager can help lead your LIMS implementation project providing any level of support and advice that you may need.  Contact our team today to discuss your validation requirements further.

 GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems