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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

Semi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer

Case Study
At a glance  A client’s current automated inspection system was old and beyond its serviceable life. A new automated filing system and semi-automated system were purchased to increase production detection capabilities for parenteral presentations.  New control system required integration with global system  Shakedown provided a faster path to successful validation   This was a new platform […]

Microsoft Dynamics 365 Computer Systems Validation

Case Study
At a glanceA medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year.  CHALLENGESThe client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute the project […]

Washington Clean Buildings Performance Standard Consulting – Now Offered by PV

Performance Validation is excited to announce we will be offering consulting services to help clients across Washington bring their facility portfolios into compliance with the new Clean Buildings Performance Standard (HB1257). HB1257 is a recently adopted legislative measure that requires existing commercial buildings over 50,000 square feet to meet or exceed energy benchmarks as defined […]

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