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We Turn Critical intoCompliant

Supporting FDA-regulated industries and building owners to deliver quality and safe products.

Our Solutions

Our clients rely on our expertise to streamline the validation process while providing a comprehensive set of deliverables based on the latest industry standards and guidelines.

CQV (Commissioning, Qualification and Validation)

Our clients trust us to provide CQV services that meet strict regulatory requirements. We balance customer needs, regulatory requirements, and industry best practices in the execution and delivery of each project.

Building Commissioning

Our building commissioning team elevates our clients’ confidence by optimizing the performance of all facility systems according to their design intent and the owner’s requirements, which saves money and energy consumption.

Temperature Mapping

With our experienced resources and vast inventory of temperature mapping equipment, our team complements your in-house teams—or performs all testing for the entire project—while offering competitive, cost-effective solutions.

CAV (Critical Airflow Visualization)

We digitally record static and dynamic airflow patterns in and around all controlled environments. Our studies—meticulously planned and documented—include an evaluation of the impact of aseptic manipulations and equipment design.

CSV (Computer System Validation)

Our CSV expertise – combined with our real-world experience using Computer Software Assurance (CSA) risk-based methods to determine the appropriate level of testing without sacrificing quality or regulatory expectations – saves our clients money and time.

CQV Medical Devices

We provide peace of mind with efficient, timely, and high-quality project work. Our experts are ready to help streamline your business operations and meet regulatory requirements for all medical devices.

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The PV Advantage

With years of experience, our team is equipped to approach challenges head-on. We thrive on the importance of quality, integrity, and teamwork, so when challenges arise, we can adapt and make necessary adjustments giving you peace of mind during every step of the project.

With a risk-based approach and our ability to adapt to your internal processes, PV provides up-to-date strategies that reflect changes in cGMPs not only to meet tight deadlines but also to offer cost-saving measures while still meeting regulatory requirements for the diverse industries we serve.

Hear from our Experts

Recent Articles and News

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Getting the most out of your smoke study 

At PV, we have a successful history of providing smoke studies to manufacturers in FDA-regulated industries. We understand the importance of accuracy and precision needed to perform a proper study for our clients. For us, it is not just about filming the scenes and writing reports. It is about assisting and guiding our clients through […]
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Ensuring Regulatory Compliance: The Importance of PPAP in Medical Device Manufacturing 

Ensuring that medical devices are manufactured to precise quality specifications is key for medical device manufacturers. Keeping this thought at the forefront of regulatory compliance issues underscores the importance of constantly fine-tuning manufacturing processes with patient safety in mind. Performance Validation (PV) has successfully worked with a global Medical Device Manufacturer based in Kalamazoo, Michigan […]
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Systech Serialization Project for Large Pharmaceutical Manufacturer

Case Study
At A Glance  Our team planned and executed the validation of a system update for a large pharmaceutical manufacturer’s pre-fill syringe Systech serialization systems. The client’s systems required updating from Microsoft Windows XP to Microsoft Windows 10, as well as upgrades to new cameras, other hardware, software, and data protection controls. All of this required […]

Brad Henry

Vice President, Indiana Division Director - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry