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 […]
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 […]
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 […]
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 […]
Digital 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 […]
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 […]
Manufacturing drug products aseptically requires the utmost care to ensure that safe and effective products can make it to patients. It starts with the facility design and construction and is immediately followed by the manufacturing equipment selection, installation, and implementation. When choosing the correct equipment and systems for manufacturing, process scientists, process engineers, microbiologists, and […]
In today’s evolving business landscape, commercial building owners and operators face increasing pressure to optimize energy usage, reduce operating costs, and minimize environmental impact. One powerful tool in achieving these objectives is an energy audit. It is a comprehensive assessment of a building’s energy performance. In this blog post, we will explore the importance of […]
In a time marked by increasing environmental awareness and the urgent need to address climate change, achieving sustainability goals has become a top priority for most building owners, developers, and operators. Among the many approaches available, building commissioning stands out as a fundamental tool for optimizing building performance, reducing environmental impact, and enhancing occupant comfort. […]
Empowering Public Health and Safety In the realm of FDA-regulated industries, the pursuit of innovation is not just about staying ahead of the curve; it’s about safeguarding public health and ensuring safety. This is the mission that drives Performance Validation (PV), and it’s the heart of the difference you can make by joining our team. […]
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.
Director of Technical Services - Donna has over 20 years of experience leading teams in Commissioning, Qualification, and Validation (CQV). Her focus has always been on pioneering equipment management, quality control, and embracing innovative practices, such as Paperless Validation.