Transcat Ireland Equipment Validation Solutions
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 efficacy of the products you sell. Stockholders and management want to know you’re preserving the organization’s precious resources by trimming excess spend from your budget. This challenge represents the proverbial “rock and a hard place.” However, it is more affordable to invest in staying in compliance than to be out of compliance.
Transcat offers a wide variety of validation services that meet many European standards. Although our primary focus is on that of the pharmaceutical and biologics industries, we also perform many required studies for food and beverage, cosmetic, industrial, and medical device companies.
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.
Our Equipment Validation Services
- 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
Learn more about equipment validation with Transcat Ireland. Contact our team today!