Equipment Validation Services from Transcat
Navigating the ever-changing regulatory environment can be tedious, expensive, and time consuming. Regulators want to know you’re doing all you can to ensure the quality and safety of the products you sell. Stockholders and management want to know you’re preserving the organization’s precious resources by trimming excess spend. The best way to meet both challenges? Stay in compliance.
Transcat offers a wide variety of validation services that meet FDA, ICH, and many European standards. Although we specialize in the pharmaceutical and biologics industries, we also perform required studies for food and beverage, cosmetic, industrial, and medical device companies.
Transcat: The Compliance Experts
Since our customers are regulated by either GMP, ASTM, GLP, or the Code of Federal Regulations, we understand that a single off-the-shelf protocol would not be enough to satisfy each customer’s diverse needs. For this reason, we customize our solutions to each customer’s specific quality system. All documents are reviewed before we arrive on site to ensure that there are no gaps, and all regulations are met.
We also understand the need for flexible scheduling and service options to minimize cost and disruptions. We can work around production schedules to maximize your operational time and minimize interruptions. We can support you with process creation/optimization, project execution, or the full suit of solutions.
Regardless of which path you choose, our technical validation team will assist in determining the scope of work and provide a detailed quote that clearly establishes the scope of the job. There is no project too large or too small for our team. We are dedicated to building partnerships and creating a great experience for every customer we serve. Our expertise includes small jobs involving only a single piece of equipment all the way up to large-scale remediation project involving hundreds of instruments.
Validation Services: Protocols and Equipment Services
We verify that the equipment does what the manufacturer says it will do. To prove that a piece of equipment is performing consistently, we perform IOPQ testing. These initials stand for:
Installation Qualification (IQ): This verifies that the unit is installed properly, including voltage, proper leveling, etc. We do not install the equipment as part of the IQ.
Operational Qualification (OQ): This is when we test the features of a unit such as the control panel, any on and off switches, alarms and 24-hour mapping for temperature units. For non-temperature units we test other features like rotation for centrifuges, pH units for pH meters, and weighing accuracies for balances.
Performance Qualification (PQ): This is what we test to ensure that the unit operates as the customer requires it to work. This process is customer specific and requires our team work with yours to define the scope of work.
Validation Services Offered:
- Refrigerator, Freezer, and Cryo Thermal Mapping Validation Services
- Oven Temperature Mapping Validation Services
- Stability Chamber and Incubator GxP Mapping Validation Services
- Autoclave Validation Services
- Laboratory Bench-Top Instrument Validation Services
- Warehouse Mapping Validation Services
Improve Program Efficiency with Paperless Validation Services
To deliver even more efficiency and collaboration, we offer an enhanced compliance process through our Paperless Compliance Services. With online collaboration tools, convenient electronic document delivery, and accessible database for record retention, you will experience faster cycle times and improved accessibility to your important documentation. Learn more about our paperless compliance services today.
