All pharmaceutical quality managers know that calibration is not optional. It is a requirement to ensure product quality and for full HC/FDA compliance. When you need to ensure that positive pressure is maintained in clean rooms, or that temperature & RH remain in ranges that maintain pharmaceuticals’ efficacy, or drug stability chambers are validated you are talking about calibrations. DegreeTek will perform these Certified Calibrations and provide Maintenance and Validations on a wide range of products & software and be compliant with 21CFR Part 11 as well as HC, FDA and GMP at regular intervals to ensure stability.
- Calibration Management Services, Audit Support, NIST & NRC Traceability, Calibration Optimization, Objective Assessments.
- FDA and GMP regulations
- 21CFR Part 11 Compliance
- Process Control Instrumentation
- Controllers, Hi Limit Controllers, Paper and Paperless Recorders
- Data Acquisition Systems
- Equipment Upgrades, Preventative Maintenance, and Troubleshooting
- Temperature & RH/monitoring and control
- Room differential Pressure/Vacuum
- Autoclave s & Sterility Chambers
- Temperature Surveys/Mapping
- Equipment validation IQ/OQ PQ