Performance Validation has earned a strong reputation for quality, integrity and teamwork when working with other vendors and contractors in providing solutions for our customers.
Our Mission is to provide the Life Science industries with technical and consulting expertise to achieve and maintain a state of compliance. We strive to provide our customers with peace of mind with respect to the management and accomplishment of project work in which we have been entrusted to complete.
We accomplish our mission by:
- executing our services with integrity,
- demonstrating teamwork in providing solutions, and
- treating employees and customers with respect and professionalism.
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 the commissioning, qualification and validation of equipment, utilities, automation, cleaning and production processes for manufacturing and laboratory facilities.
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.
Performance Validation’s project management policies and procedures are based on a combination of currently accepted standards published by TenStep Project Management™ 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.
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, the Great Lakes Chapter of ISPE, and the ASTM E-55 Committee on the Manufacture of Pharmaceutical Products. Our associates keep abreast of current industry trends through participation in the following professional organizations:
- 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)
- Association for the Advancement of Medical Instrumentation (AAMI)
- Indiana Health Industry Forum (IHIF)
- Indiana Medical Device Manufacturers Council (IMDMC)
- Institute of Electrical and Electronics Engineers (IEEE)
- Instrument Standards of America (ISA)
- International Society for Pharmaceutical Engineering (ISPE)
- Parenteral Drug Association (PDA)
- Project Management Institute (PMI)
- South Carolina Bio
- Georgia Bio