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Press Releases
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Performance Validation has earned a strong reputation for quality, integrity, and a willingness to work with other vendors and contractors in providing solutions for our customers.
Targeted levels of Support
Performance Validation provides significant depth of resources to meet peak staffing demands and a broad range of specialized skill sets from a single source. We are committed to providing our clients with up to date strategies that reflect changes in cGMPs and interpretation of regulatory guidelines. We have expertise in validating and commissioning all areas of manufacturing and laboratories: equipment, utilities, automation, cleaning and process.
Resident Validation & Commissioning Teams
An increasing number of clients see local resources as the best solution to
reducing the cost of outsourcing critical services. Through partnering
agreements with a number of major companies we have developed a unique
and highly effective approach to building resident teams in support of
long-term needs. With a proven track record, Performance Validation can now
effectively implement this approach to significantly reduce costs, and, improve quality through continuity of project management and greater retention of key resources.
Project Management Systems
Project Management is an important aspect of our overall Quality System. We have implemented a Project Leader training program and are dedicated to providing competent, qualified and certified Project Leaders for managing our customers' projects.
Our project management policies and procedures are based on a combination of currently accepted standards published by TenStep Project ManagementTM, and our validation industry experience. Performance Validation's project management process recognizes five project phases - the initiation phase, the planning phase, the execution phase, the controlling phase, and the closing phase.
Our project management philosophy for each of these project phases is to work with each customer to identify the deliverables for each of the project phases, establish a plan for completing the deliverables, identify risks in the plans and mitigate them, track performance, and adjust project plans based on the tracked performance to improve results. A solid project management program ensures that project deliverables are produced in a timely, quality, and cost-effective manner. Our customers contribute in this effort by participating in status meetings, resolving issues, making decisions on project scope changes, and reviewing and accepting project deliverables.
Involvement with Professional Organizations
Performance Validation encourages our associates to get involved in our professional and trade organizations. PV is involved in a leadership position with the Indianapolis Section of ASQ and the Great Lakes Chapter of ISPE. Our associates keep abreast of current industry trends through participation in the following professional organizations:
- American Institute of Chemical Engineers (AIChE)
- American Society for Quality (ASQ)
- American Society for Testing and Materials (ASTM E-55 committee)
- American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE)
- American Society of Mechanical Engineers (ASME)
- Association for the Advancement of Medical Instrumentation (AAMI)
- Healthcare Businesswomen's Association (HBA)
- Indiana Health Industry Forum (IHIF)
- Indiana Medical Device Manufacturer's Council (IMDMC)
- Institute of Electrical and Electronics Engineers (IEEE)
- Instrument Standards of America (ISA)
- International Society for Pharmaceutical Engineering (ISPE)
- Joint Equipment Transition Team (JETT)
- Ohio's bioscience-focused Edison Center (OMERIS)
- Parenteral Drug Association (PDA)
- Project Management Institute (PMI)
- Virginia Biotechnology Association (VABio)
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