Temperature mapping is a critical process in temperature-controlled storage facilities, especially during winter. The season’s harsh conditions pose unique challenges that must be meticulously managed to maintain product integrity. This blog delves into the specific challenges of winter temperature mapping and the necessary adjustments to ensure facilities remain compliant and efficient. 1. HVAC Heating Dynamics […]
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In this blog, we aim to assist K-12 capital project teams and owner’s representatives in Washington State by clarifying the commissioning process for school projects. We’ll highlight the differences between the Washington Sustainable Schools Protocol (WSSP) and the Washington State Energy Code, Commercial Provisions (C408), and offer insights for crafting effective Requests for Qualifications (RFQ) […]
Read MoreValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US. Performance Validation is an industry leader with over 30 years of experience […]
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Choosing the right Laboratory Information Management System (LIMS) vendor is a critical decision for any pharmaceutical or medical device manufacturing company. The right vendor not only ensures compliance with stringent regulatory standards but also enhances the efficiency and effectiveness of your laboratory operations. Here are six must-have qualities to look for in a LIMS vendor. […]
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Performance Validation an industry leader with 35 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries is proud to announce the appointment of Donna Griffith as the company’s Director of Technical Services. Donna Griffith brings a wealth of experience and expertise to Performance Validation, having […]
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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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