FDA IT Validation Services Pharmaceutical Industry Expertise Altrex has a deep understanding and is qualified to perform Validation Services set forth by the FDA 21 CFR Part 11 Compliance. CFR Part 11 is the Federal Requirement for Electronic Record Keeping for the Pharmaceutical industry. Altrex is one of the only companies in the tri-state area that provides hardware, software, and fully documented FDA services for infrastructure submittals. Our services include: Preparation of Installation (IQ), Operational (OQ) and Performance (PQ) test scripts and SOPs for the validation of Computer Systems and Storage for Pharmaceutical applications.. Maintenance of Validated Systems and changes in SOP Documentation Technical consulting (Compliant SOP Design and Development) We are uniquely qualified to perform these services with our in-house expertise in the Infrastructure area. This area has long been ignored by the Life Sciences companies and recent changes in FDA regulations have prompted companies to be more diligent in complying with proper documentation around hardware and software. Altrex currently works with both large and small Pharmaceutical and Biotech companies.