As a solution provider for system integration, HEITEC provides engineering expertise for the pharmaceutical and medical engineering industries. Pharma technicians, and engineers guarantee your project success at the highest quality standards.
As a system integrator, we realise complete projects for you in the DIN ISO 13485 and GxP context. We perform Design Qualification (DQ) and risk analyses, as well as the Installation Qualification (IQ) and Operation Qualification (OQ) with the corresponding traceability (proof of consistency). We also support you in Performance Qualification (PQ) upon request.
In consideration of your Customer/User Requirement Specification (URS) and the regulatory frameworks GAMPS, Annex 11 and FDA 21 CFR Part 11, we integrate risk-based automation, MES systems, vision systems etc. into your processes.
In order to efficiently generate and organise our and your validation documents, we have developed the software ValiManager. By structuring and standardising the validation documents, we were able to achieve a high degree of reusability. Proof of traceability is ensured as documentation content has been comprehensively linked.
We speak the language of the machine engineer and that of the operator. Speak with us!