Validation of CAQ.Net
During the qualification and validation of the CAQ.Net standard software, we support you together with our partners throughout the planning and implementation of all validation activities – for instance by providing important technical documentation such as test protocols and checklists. As one of the most experienced and long-standing providers of CAQ and 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.
Technical Features of the Software
Whether electronic signature, single sign-on, and configurable security settings or data validation by means of access and change logging with audit trail – CAQ.Net’s scope of functions includes all technical features that are required for the use as a fully validated software solution in the regulated sector.
For the use of CAQ.Net in the cloud as Software-as-a-Service (SaaS), we have taken appropriate measures to enable you to validate within this scenario as well. These include a systematic procedure for carrying out updates and upgrades, ensuring a staging environment for configuration changes and revalidations as well as a structured, tried-and-tested procedure for planning and implementing releases. This enables us to implement the measures required for such systems within the regulatory framework in a way that is tailored to meet your needs.
Validation Process
User
- Selection of modules depending on the intended purpose
- Optimization of processes
- Acceptance tests
- User satisfaction and use of the software
CAQ AG
- Installation & Configuration / Installation Verification (IV)
- Training
- Support by quality management experts
- Maintenance & improvement of the software
Validation
- Detailing the requirements
- Validation planning
- Checking the supplied system documentation & planning the supplementary tests
- Validation report
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 – for this purpose we offer you a broad range of documents and document templates that significantly reduce your workload.
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.