Computer System Validation (CSV) is crucial for any organization that needs to comply with Good Laboratory Practices (GLPs). GLPs are regulatory quality standards for conducting non-clinical laboratory studies that support the development of products for human or animal health. They require that laboratory data be reliable, consistent, and accurate. To meet these requirements, laboratories that […]
Read MoreIn today’s competitive job market, professionals aren’t just seeking a paycheck; they’re looking for a sense of belonging and an opportunity to be part of something bigger. At Performance Validation (PV), we understand this aspiration, which is why our Employee Stock Ownership Plan (ESOP) stands at the core of our culture and business philosophy. The […]
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In the high-stakes world of pharmaceutical manufacturing, equipment maintenance isn’t just a routine part of the job—it’s a cornerstone of our success and reliability. As technology evolves and the complexity of our systems increases, the way we approach equipment diagnostics must also adapt. We’re not just maintaining machines; we’re ensuring the continuous, compliant output that […]
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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, […]
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