In the fast-evolving world of pharmaceutical manufacturing, we stand at a crossroads where tradition meets innovation. As an industry, we are custodians of health, holding the safety of patients firmly in our hands. This immense responsibility, I believe, is shouldered not just by the meticulous processes we uphold but significantly by the manufacturing staff who […]
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In the pharmaceutical industry, computerized systems (hardware, software, processes) play a critical role in creating and managing data, producing products, and ensuring compliance with regulatory requirements. 21 CFR Parts 210 and 211 contain aspects which drive the need for computer system validation (CSV). Of course, there is 21 CFR Part 11 (electronic records and signatures) […]
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In the FDA-regulated industry, staying ahead of technological advancements is paramount. At Performance Validation (PV), we understand the evolving needs of our clients and are committed to delivering cutting-edge solutions that transform traditional practices. Introducing the new era of smoke studies and critical airflow visualization – a game-changing approach that empowers clients with unprecedented capabilities […]
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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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