EngiSystems' team includes exceptional engineers ready to resolve even the most complex challenges. Our professionals focus on software validation for Medical Device Software, Computerized Systems such as ERP, Equipment Software for manufacturing and laboratory environments, and IT Infrastructure Qualification for servers and routers. We understand the sophisticated tools and methodologies necessary to validate systems that meet the FDA's stringent requirements.

EngiSystems' offers proven success in test method validation and Equipment Qualification/Process Validation (IQ, OQ, PQ). Our validation methodologies are carefully derived from FDA requirements leveraging deep industry experience and knowledge of compliance protocols. This insight allows us to employ the validation model(s) best suited for each assignment to deliver repeatable, cost-effective results.

CA/PA initiatives are key components of a sound Quality Management System (QMS) and Good Manufacturing Practice (GMP). To ensure these actions are effective, a thorough, systematic investigation and root cause analysis is essential. Our experts bring the experience and technical know-how to recommend the appropriate corrective and preventive actions.
News & Events


EngiSystems featured on Fox Business, Bloomberg and CNBC for 21st Century Health Television Series

read more

"EngiSystems enables Medical Device and Pharmaceutical manufacturers to bring safe,
high-quality innovations to market quickly and profitably by being the global leader in
forward-thinking, turnkey FDA compliance solutions."