Validation of process-supporting tools

In regulated environments (medical technology, automotive, etc.), the tools used for development and production are often subject to similar quality requirements as the products to be developed themselves. This applies to both hardware and software. For example, a test environment must provide reliable artifacts that allow both the tested product to be reliably evaluated and to withstand quality audits. The performance of the processes must also be verifiably tested.

Formal validation of the test environment is particularly useful, sometimes essential, for audits, but also for corresponding improvements to the quality and efficiency of the test environment. However, the supposedly high cost of initial validation and possible regression (e.g. when integrating new tools) often speaks against this.

The two-day training course shows how an economically viable yet high-quality validation of process-supporting tools can be carried out, with a focus on software tools. The procedure is based less on the complete functionalities of the tools used and more on the procedures in the process and the regulations applicable in the respective environment (e.g. 21 CFR 11 in medical technology).

An overview is given and discussed of how the individual analysis and validation steps should look in typical industrial environments. This will enable participants to approach the validation of test environments effectively and efficiently and to handle them in an economically viable manner.