Excellence in Calibration, Validation, and Repair Services
Equipment Validation Services
As industry professionals, you are faced with the ongoing challenge of ensuring the quality, safety, and efficiency of your products, while also managing guidelines established by the FDA and global regulatory bodies. Equipment validation is an important aspect of quality assurance. It provides documented evidence that your systems, facilities and processes perform their intended functions according to established specifications.
SiteCal’s validation service will deliver distinct advantages for company’s required to perform validation of there processing and manufacturing equipment. We have in-depth knowledge of process/manufacturing equipment and the information to fulfill regulatory requirements. With each study, we offer:
- Validation technicians with extensive technical expertise
- Protocols that satisfy ISO, GMP/GLP guidelines
- Qualification, validation and re-validation capabilities
- The delivery of validation documents
- A proven record of validations performed for the industries we serve
What We Do
We conduct validations when a new system or piece of equipment at your facility is adopted and needs to be qualified for use or when a periodic re-qualification study is needed. Our qualification/validations are created to meet our customer’s quality system requirements. We provide installation, operational and performance qualification services for all types of chambers requiring documented mapping distribution of temperature, humidity, CO2 and O2. We also offer full steam sterilizer and dry heat oven validation services.
With flexibility in scheduling and an understanding of your work loads, SiteCal can conduct validations in conformance to industry regulations with custom written protocols. We can follow your established protocols or write protocols specifying your specific details, such as acceptance testing requirements. For more information on our validation services for your business, contact us today.