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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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. […]
Read MoreAn energy audit is the process of reviewing all energy-consuming features of a building, classifying the end-uses of the energy consumption (HVAC, lighting, plug loads, etc.), looking for high energy end-uses and making recommendations for Energy Efficiency Measures (EEMs). Simple payback calculations are typically provided for each EEM and are prioritized to provide the building […]
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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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