Validation consultants play a key role in assisting biotech, medical device, and pharmaceutical companies to manufacture high quality products consistently.

How do validation consultants do this? In a nut shell, validation engineers write formal test procedures called protocols to challenge manufacturing equipment, computer software, and even the test equipment used to accept or reject medical device products. The results are then summarized in a validation report.  These protocols and reports serve as objective evidence that predetermined acceptance criteria for a medical device can be consistently met.

Validation is a regulatory requirement for compliance to the Food and Drug Administration’s (FDA) code of federal regulations, and is intended to mitigate the risk of defective or poorly designed products from causing harm to patients.

Companies often hire validation consultants to alleviate the demand that validation activities create on their full time engineering staff. This allows company resources to focus on research and development as well as day-to-day manufacturing operations needed to remain competitive in today’s healthcare marketplace.

Validation Consulting Inc. assists clients with   Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Performance Qualification (PPQ) and Validation Master Plans (VMP). Our consultants specialize in the following core competencies of validation;

Validation is our niche. Our solutions are comprehensive and encompass the full spectrum of quality, compliance, and validation services. Unlike any other service provider, our core team consists of engineers who work in industry and specialize in identifying and placing the right people for your project.

Our validation consultants and subject matter experts support short and long-term project assignments. We have a proven track record of providing validation services and measure our success through complete customer satisfaction. Contact us and see what makes us different!