In the regulated industry environment SpiraTec observes recognised guidelines and legal requirements throughout the entire project. The ensuing compliance is implemented in close coordination and cooperation with you, the client.
GMP conform planning
Compilation of risk-analysis
Compilation of SOP
Supervision of the implementation according to GAMP
Coordination and testing of the QM documentation of PU and machinery suppliers
Accomplishment of DQ, IQ, OQ, PQ for systems of the production and production management (PIMS, LMS, etc.)
Support with IQ, OQ, PQ of plants together with process engineering