A Veteran-Owned Company  • Charter Founder, Great Lakes Chapter, ISPE

Office Locations: Indianapolis, IN • Kalamazoo, MI

The Performance Validation Advantage

Full Time Staff

PV's employees are full-time, salaried employees, each of which has attained a 4-year technical degree.  As one project comes to a close, our staff members do not have to worry about where and when the next one will begin.  We make a commitment to each of our employees, and it is reflected in their loyalty.  Each project is an event along the continuum of a career, not just a job.

Quality System

All of PV's business activities are governed by our Quality System, which was developed to comply with ISO9000:200 and 21 CFR Parts 211 and 820.  PV's Quality Unit consists of the President of Performance Validation as the Management Representative, a Quality Manger who is an American Society for Quality(ASQ) Certified Manager of Quality (CQM/OE), and Quality Assurance Liaisons to provide quality expertise at the divisional level, supplemented by ASQ Certified Quality Auditors (CQA) to perform our internal audit function.

 

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 our internal CAPA process.

Project Management Systems

Project Management is a critical aspect of our overall Quality Systems.  Each project that PV undertakes is led by a Project Leader, who has been certified through PV's internal Project Leadership Training Program, which is based on the Project Management Institute (PMI) TenStep Project Management Process.  This training provides our Project Leaders with the widely recognized management principles of PMI, along with the project management elements of PV's Quality Systems, which ensures a consistent application of project management skills throughout the organization.

Professional Development

PV invests in each of its employees through ongoing technical and managerial training, encourages participation in industry organizations, and supports the  ongoing education of our staff through the achievements of certifications and advanced degrees.  Among the certifications that our staff hold are:

  • Professional Engineer (P.E.)
  • ASQ Certified Quality Auditor (CQA)
  • ASQ Certified Manager of Quality/Operational Excellence (CQM/OE)
  • PMI Project Management Professional (PMP)
  • ISO 13845 Auditor

 

PV Actively participates in the following organizations:

  • American Society for Testing and Materials (ASTM) E2500 Committee
  • International Society of Pharmaceutical Engineers (ISPE)
  • American Society for Quality (AS)
  • American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)
  • Project Management Institute (PMI)
  • Parenteral Drug Association (PDA)
  • Building Commissioning Association (BCA)