Prove your system meets regulatory requirements using LIMS Validation.

What is LIMS validation?

Typical steps to LIMS validation

There are many aspects to LIMS validation. A detailed User Requirements Specification (URS) is the critical foundation stone because companies must demonstrate that their LIMS fulfills these requirements.

A Functional Specification (FS) is developed to match the URS and defines the LIMS functionality. Other critical steps towards LIMS validation include:

  • Creating a System Validation Plan
  • Verifying adherence to 21CFR Part 11
  • Completing a Risk Assessment
  • Installation Qualification (IQ) – demonstrates correct installation of the LIMS
  • Operation Qualification (OQ) – proves the LIMS operates as expected
  • Performance Qualification (PQ) – confirms the performance of the LIMS in a customer environment with customer data

Once these steps are successfully completed a final LIMS Validation Report is created and signed-off that captures the process and the results.

LIMS Validation

LIMS validation of configurable systems

Using Autoscribe's LIMS validation services

21CFR11 checklist

FDA 21CFR Part 11 principally defines the criteria related to electronic signatures that must be implemented. Download our 21CFR11 checklist to discover how Matrix Gemini LIMS meets these requirements

21 CFR11 Cover

LIMS Validation

Download the "LIMS System Validation" White Paper

Discover what "best practice" LIMS validation looks like.

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