Validation Services

As a industry professional, 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, Inc. validation services will deliver distinct advantages for company’s required to perform validation of there manufacturing and process equipment. We have in-depth knowledge of process/manufacturing equipment and the information to fulfill regulatory requirments. 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 qualifications/validations are created to meet our customer’s quality system requirements. We provide installation, operational and performance qualification services for all types of chambers that require mapping of temperature, humidity, CO2 and O2. We also offer 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 regulations with custom written protocols. We can follow your plan or write a precise protocol specifying details, such as equipment to be used and the testing requirements. For more information on our validation services for your business, contact us today.