At A Glance An Indianapolis-based contract development and manufacturing organization (CDMO) for injectable pharmaceutical manufacturing partnered with Performance Validation (PV) for cleanroom recovery testing. During a client’s compliance audit relating to ISO 14644 and EU Annex 1 requirements, the CDMO realized they lacked proper testing documentation demonstrating room recovery requirements. This discovery led to the […]
Read More
At a Glance An Indianapolis-based logistics company looking to cold-store vaccines partnered with Performance Validation (PV) to validate its electronic quality management system (eQMS). The logistics company, which had GMP storage facilities with walk-in freezers, wanted to use their extra space to stockpile COVID-19 vaccines. Before this could happen, however, the company would need to […]
Read More
At A Glance One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to perform environmental mapping in its brand-new facility in Research Triangle Park, North Carolina. The pharmaceutical manufacturer expanded its operations by building a new campus to increase production capacity. One of its buildings included a quality control laboratory […]
Read More
AT A GLANCE An equipment manufacturer of high-speed automated assembly machines in Illinois partnered with Performance Validation (PV) to validate its drive/reject assembly machine. The equipment manufacturer was a vendor for one of the largest pharmaceutical manufacturers in the Midwest. The pharmaceutical manufacturer needed to produce more auto-injector pens for its drug products, so it […]
Read More
AT A GLANCE One of the largest pharmaceutical manufacturers in the Midwest partnered with Performance Validation (PV) to inspect its vial production process. The pharmaceutical manufacturer had two main objectives: The PV team had nearly a decade of experience supporting the inspection process for the pharmaceutical manufacturer, which allowed them to build expertise with the […]
Read More
At A Glance The Performance Validation Team completed a comprehensive commissioning project for the brand-new Benton County Administration Building in Kennewick Washington. The project broke ground in July of 2020, and reached completion in March of 2023. The new administration building spans three stories and encompasses 41,419 square feet, including a fully equipped basement. This […]
Read More
AT A GLANCE A top 5 pharmaceutical manufacturing company in North Chicago, Illinois, partnered with Performance Validation (PV) to perform smoke studies in a building with 14 different areas for packaging, filling, mixing, and bottling. For each area, the team conducted three scenes: a baseline, a material airlock examination, and a personnel airlock examination. The […]
Read More
AT A GLANCE The Performance Validation Team expertly conducted a comprehensive commissioning project as the primary commissioning authority for the City of Marysville Civic Center. This new facility is a cornerstone of the downtown redevelopment plan, designed to create a one-stop campus for city services. Spanning 101,000 total square feet, the Civic Center integrates a […]
Read More
Based on the increased use of computer systems in the pharmaceutical industry,the United States Food and Drug Administration (US FDA) issued the 21 CFR Part 11regulations in March of 1997. This regulation provides the criteria for acceptance bythe FDA, under certain circumstances, of electronic records, electronic signatures,and handwritten signatures executed to electronic records as equivalent […]
Read More
AT A GLANCE The Performance Validation Team successfully completed a comprehensive commissioning project of Olympic Middle School for the Auburn School District. The new facility, supporting grades 6 – 8 was constructed on the existing site while the previous facility remained operational. After the new facility’s completion, the previous building served as an interim school […]
Read More
