Pharmaceutical Industry

As a solution provider for system integration, HEITEC offers its engineering expertise to the pharmaceutical and medical technology industries. As a system integrator, we implement complete projects for you in the DIN ISO 13485 and GxP environment, starting from Design Qualification (DQ) through Risk Analysis to Installation Qualification (IQ) and Operational Qualification (OQ) with appropriate traceability. Upon request, we also support you with Performance Qualification (PQ). Taking into account your Customer/User Requirement Specification (URS) and the regulations GAMP5, Annex 11, and FDA 21 CFR Part 11, we integrate risk-based automation, MES systems, vision systems, etc., into your processes. We speak both the language of the machine builder and that of the operator.