FDA-Compliant quality and Service making the difference
Monitoring of storage and production environments has become an important issue within the Pharmaceutical Industry. The FDA and other regulatory bodies require not only accurate measurement and storage of room parameters but if the storage medium is electronic then the methods used must comply with 21 CFR Part 11. High product quality in pharmaceutical applications can only be achieved if all the relevant steps of a process are carefully defined and measuring results are precise and reproducible. Complete documentation of each single step is of highest priority.

Design qualification (DQ )
The functional , operational and technical specification have to be defined.

Installation qualification (IQ)
Following basic installation and initial calibration, the equipment is ready for testing.

Operational qualification (OQ)
Before used in the process, the guaranteed performance has to be checked and recorded.

Performance qualification (PQ)
Periodically preformed system tests guarantee functionality.

Service

Validation consulting