Does a DMS have to be validated?
Yes – as soon as the document management system supports quality-relevant processes (e.g. SOP approvals, training records or audit documentation), validation in line with GxP requirements is necessary. We support risk-based validation including URS, risk analysis, test documentation and release – practical and inspection-proof.
How long does a rollout take?
It depends on the starting point: for a new company, implementation is usually completed within 4–8 weeks. Integration into existing systems normally takes around 4–6 months. With structured project planning we ensure an efficient rollout without unnecessary strain on your day-to-day business.
Can existing systems be integrated?
Yes. In most cases existing systems such as merchandise management, temperature monitoring or training platforms can be connected. We assess the interface capability in advance and develop an integration concept that takes your existing IT structure into account.
What does a digital QMS cost?
The cost depends on system scope, number of users and validation effort. In addition to licence costs, implementation, training and, where applicable, validation should be considered. After a short needs analysis we are happy to prepare a transparent quote with a clear cost structure.
Is it GDP-/GMP-compliant?
Yes – the systems we implement meet the requirements of the EU GDP and EU GMP guidelines as well as relevant regulatory requirements (e.g. 21 CFR Part 11 where needed). Importantly: not only the system has to be compliant, but also its configuration and use. That is why we always combine system rollout with process consulting and validation.