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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 experts utilize Computer System Validation (CSV) practices to rigorously assess, document, and verify that computer systems meet predefined requirements and regulatory standards, ensuring their integrity, reliability, and compliance throughout their lifecycle.

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.

CSA (Computer Software Assurance)

Our team effectively utilizes Computer Software Assurance (CSA) techniques to assess and manage the risks associated with computer software systems, ensuring their reliability, quality, and compliance with regulatory standards.

PPAP (Production Part Approval Process)

Performance Validation offers comprehensive support to our clients in navigating the Production Part Approval Process (PPAP), ensuring that their manufacturing processes are capable of consistently delivering parts that meet customer requirements while complying with industry standards and regulations.

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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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Finding the Perfect CQV Partner: Establishing Data Governance for Pharma Manufacturing

In the fast-paced world of pharmaceutical manufacturing, ensuring regulatory compliance and maintaining data integrity are crucial for success. That is why finding the right Commissioning, Qualification, and Validation (CQV) partner is essential. This blog explores the key factors that pharmaceutical manufacturers should consider when seeking a CQV provider to establish robust data governance practices.  Establishing […]
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Hardware and Control System Upgrade to an Illinois pharma manufacturer’s Lyophilizer Cart

Case Study
AT A GLANCE A pharmaceutical manufacturer in Illinois requested Performance Validation’s expertise to carry out a two-stage upgrade for their existing process responsible for sterilizing, filling, freeze-drying, offloading, and capping vials. The first stage of the project focused on two large lyophilizers and were executed while production was ongoing, while the second stage focused on […]
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Streamlining Medical Device Validation: A Risk-Based Approach to Computer Software Assurance

Computerized systems (hardware, software, and processes) play a critical role in the medical device industry. They are used to create and manage data, produce products, and ensure compliance with regulatory requirements.  Computer system validation (CSV) is the process of ensuring that computerized systems meet their intended requirements and can consistently produce accurate and reliable results. […]

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