LIMS system validation is essential to prove compliance in regulated industries.

LIMS System Validation is important in regulated industries to prove your system operates as intended and meets regulatory requirements. There requirements impose specific controls and procedures throughout the development of the system.

This white paper describes Autoscribe's approach to LIMS validation to meet these stringent requirements.

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Cover System Validation WP

In this system validation white paper you will learn:

  • What LIMS Validation is
  • Autoscribe's approach to system validation
  • The steps involved in validation
  • What the customer's responsibilities are
  • How GAMP 5 affects LIMS validation
  • System validation deliverables
Preview extract

Introduction

Matrix Gemini LIMS and the related family of software products are widely used by companies that need to comply with the regulations created by the FDA and equivalent regulatory bodies.
To be suitable for use in regulated industries the functions of these applications must be verified. The purpose of this paper is to summarize how Autoscribe can help with the validation processes that need to be performed.

Autoscribe Informatics have over 30 years’ experience in building and implementing LIMS in regulated compliant laboratories. Supporting Matrix customers with their regulatory needs is a very high priority and whereas, it is still the responsibility of our customers to prove their compliance with the regulatory authorities, Autoscribe will do its best to support them.

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