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AT A GLANCE Our team conducted a comprehensive two-phase commissioning process for a recently constructed high school and performing arts center within the Snoqualmie school district. Our primary objectives were to ensure the energy efficiency of the buildings, guarantee their seamless operation, and provide the training and tools to empower the maintenance team to keep […]
Read MoreAT 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 […]
Read MoreAt 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 […]
Read MoreAt A Glance Our team conducted a comprehensive 1-day smoke study for a pharmaceutical client based in Illinois. Although this study was not mandated by the Food and Drug Administration (FDA), it held immense significance for our client. The primary objective was to verify the safety of their employees throughout the production process of a […]
Read MoreAt 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 […]
Read MoreAT A GLANCE: A major pharmaceutical manufacturer near Fort Collins, CO required a team of skilled and experienced professionals to complete a smoke study within their aseptic syringe filling suite. DIFFERENT APPROACH TO FIT CLIENT’S NEEDS When Performance Validation (PV) initially met with our client; they stressed the importance of requiring a team of experts […]
Read MoreAt 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 […]
Read MoreAt 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 […]
Read MoreOverview A global pharmaceutical manufacturer was looking to boost its production capacity due to high market demand but was running out of space at its largest U.S. facility. The manufacturer’s team decided to recapitalize its existing warehouse space to make room for a new device line. After a rigorous qualification process, the manufacturer procured a […]
Read MorePharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q The Challenge A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration […]
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