Control Systems Integration Design & Engineering

Validation

HiTech offers cGMP services for pharmaceutical, biomedical, and medical device industries. HiTech is uniquely qualified to not only understand our clients operational and financial challenges, but to also supply our clients with solid validation assessment, preparation, execution and documentation.

HiTech strives to be an extension of our client's Validation Department. By combining a life cycle methodology based on GAMP guidelines and strong internal procedures such as change control, software development, and 21 CFR part 11 compliance.  HiTech provides flexible and diverse validation support packages.

HiTech’s capabilities encompass master plan preparation, regulatory auditing, and IQ/OQ/PQ protocol development / execution for a wide range of equipment, processes, cleaning, computer and automated systems.