FDA Compliance Services

Why Compliance Services?

Navigating the ever-changing regulatory environment is tedious, expensive, and time consuming. Regulators want to know you're doing all you can to ensure the quality, safety, and efficiency of the products you sell. Stockholders and management want to know you're preserving the organization's precious resources by trimming every last excess dollar out of your budget. This challenge represents the proverbial "rock and a hard place." Being in compliance is more affordable than being out of compliance.

Why Transcat Compliance Services?

• Decades of industry experience in the fields of validation, calibration and analytical instrumentation
• Focused on partnership with customers and customer experience
• Expertise for small jobs with a single piece of equipment or large scale remediation project with hundreds of instruments
• Are available for every step of the customer process
• Full-scale compliance audits of existing systems
• Remediation of existing systems
• Ongoing preventive maintenance
• Revalidation needs

Focusing on the pharmaceutical, medical device and biotech industries, we want to be the partner for all your ongoing compliance needs, not a drive-by service organization that fails to see your bigger picture.

Contact us about Compliance Services Today! 1.800.285.9822

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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