Performance Validation

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Performance Validation provides quality, validation, commissioning and consulting services to the Pharmaceutical, Medical Device, Biotechnology and allied industries. Since our business supports the start up and ongoing operation of GMP compliant activities regulated by the US Food and Drug Administration, we believe our Quality Unit is essential to the success of our business and our customers' business.

Performance Validation's Quality Unit consists of the President of Performance Validation as the Quality Manager, and Quality Assurance Liaisons to provide quality expertise at the divisional level.  All members of the Quality Unit have obtained American Society of Quality (ASQ) certifications and are members of ASQ. Performance Validation has a number of personnel who have obtained ASQ quality certifications who may assist the QM or QAL in the performance of internal audits of our Quality System or in executing Six Sigma continuous improvement projects.

The Quality Unit functions include approval and control of internal documents and procedures including corporate policies, project management systems, validation guidelines, and testing procedures essential to the control of the day to day business operations. The Quality Unit is also responsible for internal project audits, critical equipment controls, customer feedback, training systems, and investigation of formal complaints.

Performance Validation's Quality System is designed to comply with ISO 9000:2000 and 21 CFR 820 and 211. Our Quality Management System (QMS) has been approved and implemented.  

Project Quality Control functions including peer review and shake down activities are the responsibility of the certified Project Leaders. Performance Validation Project Leaders are trained in cGMP requirements and are fully capable of routine quality reviews.