Watch our video on how Integrao is providing engineering, compliance, commissioning and support services to today's businesses.
Serving Companies with Critical Facilities in the Pharmaceutical, Biotech, Semiconductor and Data Center Sectors
We UnderstandThe compliance, operating, equipment and facilities challenges facing
compliance21 CFR Part 211 and ASHRAE 0-2019
Good documentation is essential for pharmaceutical and biotechnology manufacturing facilties to achieve regulatory compliance. As defined by the FDA , “validation is the documented process of demonstrating that a system or process meets a defined set of requirements.” The Integrao team works with our clients’ cross functional teams to ensure that all testing documentation for building and process systems can be leveraged for the validation process. We generate test protocols, perform tests, and commission systems according to Industry Standards such as: ASHRAE Guideline 0-2019, ASTM E2500-13, and FDA Pharmaceutical cGMP's for the 21st Century - A risk based approach. Check out our services tab for more details.