Validation of CAQ.Net

As one of the most experienced and long-standing providers of Quality Management Software solutions for the life science sector, we have profound expertise in the area of software validation / CSV (Computerized System Validation) and have already supported several of the most renowned companies in the medical device industry and pharmaceuticals throughout the successful implementation of our solutions.

V model for validation — V-model for validation

Technical Features of the Software

Our configurable standard software CAQ.Net actually fulfills the requirements of a successful validation all by itself.

Whether electronic signature, single sign-on, and configurable security settings or data validation by means of access and change logging with audit trail – CAQ.Nets scope of functions includes all technical features that are required for the use as a fully validated software solution in the regulated sector.

Validation Services within the Quality Excellence Network

CAQ.Net’s unique technical features allow you to carry out the validation process completely on your own. Of course, we are happy to support you throughout all validation steps together with our validation partners of the Quality Excellence Network and offer you a scalable validation portfolio, from which you can choose the scope that suits you best.

Use in Regulated Environments

Join the Best: users with validated CAQ.Net software report on the daily use of our solutions.

Frequently asked questions about software validation

What is software validation?

The U.S. FDA defines software validation as "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." Thus, software validation should be understood as a documented process to consistently and reproducibly ensure that a computer system does exactly what it was designed to do.

For whom is software validation relevant?

Software validation is a component of the Quality System Regulation issued in 1996 under Title 21, Code of Federal Regulations (CFR), Part 820 and is addressed in more detail, for example, in FDA 21 CFR Part 820.70 (Production and Process Controls) or FDA 21 CFR Part 11.10 (Controls for Closed Systems). Corresponding requirements can be found in ISO 13485:2016 Chapter 4.1.6 ("Software Validation") and the relevant GMP guidelines and GAMP regulations. Thus, almost all companies in the life science industry (medical devices, medical technology, or pharmaceuticals) are obligated to validate their software products.

More information regarding CAQ.Net in regulated industries



Medical Technology



Pharmaceuticals
        

Food Industry