LIMS systems are used extensively in laboratories everywhere. As a tool in the lab we need to be able to trust the system to have the necessary data integrity. Just like the analytical methods, also the tool LIMS must be validated. Otherwise: How can you trust the system? Validation of tools like LIMS is a part of all lab standards; the GxP and ISO 17025 to mention a couple. This short presentation will cover the approach to validation of LIMS. The same approach can be used for all other IT systems including the instrument systems in the lab. Tools in the process are also mentioned.

Learning Objectives:

1. Approach to validation and which tools to use

2. Content of the validation plan and its parts, including how to create test plans and document the testing

3. On-going validation