Explaining LIMS Validation

Within regulated environments, LIMS validation is a vital process, and yet is a subject that is open to many different interpretations. Regulatory bodies throughout the world, such as the US Food and Drug Administration (FDA), require that software systems be tested and proven to work as intended. LIMS validation is therefore essential within such regulated environments to ensure data integrity and prove compliance. The need for validation is also enshrined in various international standards including, for example, ISO 17025 General requirements for the competence of testing and calibration laboratories.

This informative webinar has been developed using Autoscribe’s many years of industry experience to explain LIMS validation and how the validation of your LIMS should be approached. It is presented by Scott Krieger, Director of Technical Services at Autoscribe Informatics. Scott has extensive experience in both the laboratory and in laboratory informatics. The topics covered include:

• What is LIMS validation?
• When is LIMS validation needed?
• Adopting a risk-based approach to validation
• A typical LIMS validation process
• Consulting vs in-house resources
• Configuration and GAMP categories, what you need to know
• Planning your LIMS Validation

The webinar is an essential learning aid for all involved with quality assurance and the use of LIMS in regulated environments. It arms the audience with a methodology to drive a risk-based approach to LIMS validation and provides the information needed to decide if validation is required. After this webinar viewers will have the confidence to take the next steps towards a successful LIMS validation project.  

The webinar can be viewed below.