As a solution provider for system integration, HEITEC provides its engineering expertise to the pharmaceutical and medical engineering industries. Pharmaceutical technicians and engineers guarantee your project’s success with the highest quality standards.
As a systems integrator, we implement complete projects for you in the DIN ISO 13485 and GxP environment – from design qualification (DQ) and risk analysis to installation qualification (IQ) and operation qualification (OQ) with corresponding traceability. At your request, we’ll also assist you with performance qualification (PQ).
Taking into account your Customer/User Requirement Specification (URS) and GAMP5, Annex 11 and FDA 21 CFR Part 11 regulations, we integrate risk-based automation, MESs, visualization systems, and more, into your processes.
- Validation and qualification
- Automation systems
- Software development
- Measurement and testing systems
- Central control systems
- Digital engineering
We developed the ValiManager software to efficiently generate and organize our own and our customers’ validation documents. Thanks to the structuring and standardization of specification and verification content, a high degree of reusability is achieved. The comprehensive linkage of content permits proof of traceability.
We speak the language of both machine builders and machine operators.