Graham-Kapowsin High School Health Center Case Study 

At a Glance:  The Performance Validation Team completed a comprehensive commissioning project for the expansion and renovation of the Graham-Kapowsin High School Health Center, situated within the Bethel School District. This initiative aimed at significantly enhancing energy efficiency, operational proficiency, and ensuring seamless system functionality across 60,000 square feet of classrooms, an auxiliary gym, and […]

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Dual Component Vial Production Line Validation at a Leading Pharmaceutical Manufacturer in Kalamazoo, MI 

At A Glance: A well-established pharmaceutical manufacturer in Kalamazoo, Michigan, embarked on a critical initiative to upgrade their production capabilities, focusing on the implementation of a dual-component vial system. Recognizing the complexity and importance of this project, the manufacturer entrusted Performance Validation (PV) as their validation partner. PV’s expertise was vital in addressing the evolving […]

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Critical Utilities Periodic Review Implementation for Global Pharmaceutical Manufacturer 

At A Glance A prominent pharmaceutical manufacturer on a global scale was seeking to integrate periodic reviews in their quality process to detect qualification gaps, undocumented system modifications, deviation trends, as well as maintenance and calibration issues, negative trends in system performance, and inadequacies in the development of required legacy documents. In collaboration with the […]

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Systech Serialization Project for Large Pharmaceutical Manufacturer

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 […]

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

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 […]

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Microsoft Dynamics 365 Computer Systems Validation

At a glance: A 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.  CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]

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