By Robert Perks, Director of Digital Solutions at Performance Validation In today’s fast-paced pharmaceutical industry, the ability to streamline operations while maintaining the highest standards of compliance and data integrity is more important than ever. At Performance Validation, we have seen firsthand how the transition to paperless validation is not just a technological upgrade—it is […]
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In the rapidly evolving pharmaceutical industry, the rising costs of drug development present significant challenges. From the 1970s to the 2020s, development costs have increased dramatically, posing hurdles for biotech and pharmaceutical companies. Contract development and manufacturing organizations (CDMOs) have become a strategic solution, with the global CDMO market projected to grow significantly in the […]
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In the highly regulated field of medical device manufacturing, ensuring that every part and component meets rigorous quality standards is essential. One of the first and most critical steps in the Production Part Approval Process (PPAP) is Identifying Requirements. Performance Validation (PV), a leader in PPAP services for medical device manufacturers, emphasizes the importance of […]
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Energy audits are an invaluable tool for identifying opportunities to improve energy efficiency, reduce operating costs, and enhance building sustainability. A comprehensive energy audit involves a systematic evaluation of a building’s energy consumption, efficiency, and performance. Today we will provide an energy audit checklist outlining essential steps for conducting a thorough and effective energy assessment. […]
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North Carolina leads the southeastern United States in research and manufacturing in the pharmaceutical and biotechnology spaces. The state has key manufacturing sites spanning from the mountains to the coastal plain, and ranging from small molecule to complex biotechnologies. What started in the state as typical pharmaceutical production and processing, has developed into advanced biotechnology […]
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In pharmaceutical and medical device manufacturing, the qualification of equipment and systems is a critical component of ensuring that they operate as intended, consistently producing high-quality products. The qualification process is divided into three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each stage plays a vital role in verifying that […]
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Building commissioning plays a crucial role in ensuring that buildings operate efficiently, sustainably, and in accordance with their intended design. However, despite its importance, there are several myths and misconceptions surrounding the practice of building commissioning. In this week’s post, we will debunk some of the most common myths about building commissioning and shed light […]
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Building envelope, also known as building enclosure, is a critical component of any structure. It serves as the primary interface between interior and exterior environments, providing protection, insulation, and structural support. We are going to explore the importance of building envelope for today’s blog. The goal will be understanding the role it has in creating […]
Read MoreDigital transformation is more than a buzzword; it is a comprehensive journey that reshapes how organizations operate, innovate, and deliver value. In FDA-regulated industries such as pharma manufacturing and medical device production, digital transformation is not just about integrating new technologies but about rethinking processes, culture, and leadership to drive sustainable growth. Robert Perks, a […]
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Commissioning is a critical component in ensuring that buildings operate efficiently, reliably, and in accordance with their design intent. While commissioning can generally be associated with new construction projects, it is also largely important for existing buildings and facilities. Today we will be exploring the strategies for retro-commissioning and continuous optimization of existing buildings, highlighting […]
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