As a medical device manufacturer, you understand the importance of meticulous documentation. This documentation exhibits effective evidence that the critical aspects of your medical devices – including design, manufacturing, and quality control processes – are validated. By maintaining comprehensive documentation, you can demonstrate that your devices meet your specifications, customer specifications, and stringent regulatory requirements, […]
Read MoreDuring an FDA inspection in June 2023, several violations related to computer system / software compliance and general quality system processes were identified. Here is a link to the letter: Warning Letter CMS #653455 The warning letter details a variety of violations that can be addressed through computer system validation (CSV), computer software assurance, equipment […]
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As a building owner, you understand the importance of caring for and keeping your building running smoothly. However, over time, building systems and components can become less efficient or fail altogether. That is where existing building commissioning comes in. What is Existing Building Commissioning? Existing building commissioning (EBCx) is the process of optimizing the performance […]
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Summer is here, and that means it is time to start thinking about temperature mapping. If you store or transport temperature-sensitive products, it is important to make sure that your facilities are properly controlled during the hot summer months. Temperature mapping is the process of measuring and recording the temperature at various points in a […]
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At PV, we have a successful history of providing smoke studies to manufacturers in FDA-regulated industries. We understand the importance of accuracy and precision needed to perform a proper study for our clients. For us, it is not just about filming the scenes and writing reports. It is about assisting and guiding our clients through […]
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Ensuring that medical devices are manufactured to precise quality specifications is key for medical device manufacturers. Keeping this thought at the forefront of regulatory compliance issues underscores the importance of constantly fine-tuning manufacturing processes with patient safety in mind. Performance Validation (PV) has successfully worked with a global Medical Device Manufacturer based in Kalamazoo, Michigan […]
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As the first step in your professional life, your first job after college may impact the opportunities available to you for your entire career. In this blog post, we will discuss why your first job after college matters. It’s a learning experience. Your first job is an opportunity to learn more about the industry, gain valuable […]
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Pharmaceutical manufacturing is a highly regulated industry that requires strict adherence to quality and regulatory requirements. However, staffing shortages or a backlog of projects can put companies at risk of non-compliance and costly delays. In such cases, staff augmentation services can provide an effective solution for pharmaceutical manufacturers to meet their CSV needs. In this […]
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Performance Validation (PV) is pleased to welcome Scott Council as the new Division Director for PV’s North Carolina Hub. Scott’s extensive engineering background, combined with his experience in manufacturing and FDA-regulated environments, make him the perfect fit to lead PV’s operations in North Carolina. As a North Carolina native and North Carolina State University graduate, […]
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In Food and Drug Administration (FDA) regulated industries, computer systems and software play a critical role in managing data, controlling processes, and ensuring compliance with regulatory requirements. To ensure the safety, efficiency, and quality of pharmaceutical products, the FDA has established specific regulations and guidance documents that outline the requirements for computer system validation (CSV) […]
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