Our team consists of seasoned experts in the commissioning, qualification and validation of facilities, utilities, equipment, computer systems, processes and cleaning. Our Comprehensive validation services throughout the entire lifecycle, start from risk and impact assessments, validation master plans and protocol generation through execution and closeout.
Engineering is critical for a smooth transition from conception through to procurement, installation, startup and qualification. The generation and development of requirements are critical to ensure facilities and systems are designed as specified and continue to operate as efficiently as possible. Our engineers have the experience and track record of success providing robust design solutions for our clients.
We have extensive Quality Assurance experience to play a key role in developing quality and compliance strategy for emerging and established companies. We can also provide supplemental resources for ongoing quality operations for commercial operations. This includes activities such as review of batch manufacturing records, change management, risk assessments, protocols and product disposition.
Documentation is critical. That is why our skilled Technical Writing experts are trained in the processes of the life sciences industries. With hands on experience from Engineering to Quality, our team of experts has the knowledge and background to create professional documentation that are both clear and meticulous, yet easy to read and understand.
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