Compliance Services
Calibration Service Types
Discover the Benefits of Transcat’s FDA Compliance Services
Navigating the ever-changing regulatory environment is among the greatest challenges our customers face. Without support, managing regulatory changes – and adjust your processes to meet new regulations – can be stressful, expensive, and time consuming. Compliance Services from Transcat helps ensure the quality, safety, and efficiency of the products you sell, with the data to back it up. They also help you prove the efficacy and efficiency of your resource management to external stockholders and management. – . and of course, they reduce the inevitable costs that come from being out of compliance.
Why Customers Trust their Compliance to Transcat
- Decades of industry experience with validation, calibration, and analytical instrumentation
- Customer-centered approach: we want to be your partner, not just your vendor
- Capability to handle jobs of all size – from calibrating a single piece of equipment to large scale remediation projects
- Exceptional service at every step:
- Full-scale compliance audits of existing systems
- Remediation of existing systems
- Ongoing preventive maintenance
- Revalidation needs
With expertise in the pharmaceutical, medical device and biotech industries, Transcat has the experience and the resources to be your trusted partner, addressing all your compliance needs now and into the future.
Temperature Mapping and Validation Services
- Autoclave Temperature Mapping and Biological Indication Validation
- Walk-In Stability Chamber Mapping Qualification ‚ Validation
- Stability Chamber and Incubator GxP Mapping Qualification – Parameters tested for temperature, humidity, CO2 and Photostability
- Refrigerator, Freezer, and Cryo Thermal Mapping Qualification – Validation
- Lyophilizer (Freeze Dryers) Qualification – Validation
- Oven Temperature Mapping Qualification – Vacuum/Drying/Depyrogenation
Analytical Instrument Services
- HPLC Services, Preventative Maintenance, Qualification and Repair
- GC Services, Preventative Maintenance, Qualification and Repair
- Dissolution Bath and Physical Testing
- UV-VIS Spectrophotometer and Qualification Services
- Balances and Scales
Facility and Process Validation Services
- Validation HVAC
- Validation BDM
- Validation Water
- Validation Compressed Air/Gasses
- Validation Clean Room
Software Validation
- Stand-along QMS, LIMS
- Manufacturing Automation
- BMS
Compliance Auditing and Remediation
- We evaluate existing systems for compliance to regulations (210, 211, 13485, 820, ICH)
- We provide expertise and support for process/system/procedural revisions
- We train your staff or provide ours for remediation and ongoing support
Risk Management ‚ ISO 14971 and ICH Q9
- Risk management on new and existing processes
