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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.
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