A validation career in pharmaceutical and medical devices involves ensuring that products meet the highest standards of quality, safety, and regulatory compliance. Validation professionals test and document processes, equipment, and systems to confirm they perform as intended. This field offers opportunities for collaboration, problem-solving, and contributing to the development of safe and effective healthcare products. […]
In today’s world, people spend a significant portion of their time indoors, the comfort and well-being of occupants has become a paramount consideration in building design and operation. Poor indoor air quality, inadequate temperature control, and other comfort-related issues can have a significant impact on occupant health, satisfaction, and even productivity. Fortunately, existing building commissioning […]
The Critical Role of TMV in Medical Device Validation Test Method Validation (TMV) is a fundamental requirement in the medical device industry, ensuring that testing processes deliver accurate, repeatable, and reliable results. Without validated test methods, manufacturers risk inaccurate measurements, regulatory non-compliance, and compromised product quality—all of which directly impact patient safety. TMV is not […]
When it comes to pharmaceutical manufacturing, precision and adherence to regulations are paramount. Among the many processes critical to ensuring product safety and compliance, sterile preparation (sterile prep) stands out as a fundamental and indispensable step. But why is sterile prep so important, and how can pharmaceutical facilities maintain the highest standards of compliance? This […]
As the emphasis for sustainability and energy efficiency continues to expand, retrofitting building envelopes in existing buildings and structures has become increasingly more important.Retrofitting involves upgrading several different key components of a building’s exterior to improve the energy efficiency, indoor occupant comfort, and overall performance of the building. Today we will dive into the primary […]
Starting a new job is a big step. At Performance Validation (PV), we’ve built a training program with your success in mind, designed to help you grow professionally, gain valuable skills, and hit the ground running. Here’s a look at how we ensure our team members are equipped for success from their first day: 1. […]
In the ever-evolving pharmaceutical manufacturing landscape, innovation is key to maintaining efficiency, safety, and compliance. One such innovation that has gained significant traction in recent years is the adoption of single-use technology (SUT). However, the successful implementation of single-use systems requires a thorough understanding of their unique characteristics and careful evaluation of their compatibility with […]
In a time where sustainability and energy efficiency are paramount, businesses and organizations are increasingly turning to enhanced energy audits as a strategic tool for identifying opportunities to reduce energy consumption, lower operating costs, and minimize their overall environmental impact. Traditional energy audits provide a basic overview of energy usage and potential savings opportunities. Enhanced […]
Artificial Intelligence (AI) is reshaping the life sciences industry, particularly in validation processes. By introducing data-driven insights, automation, and real-time monitoring, AI is advancing efficiency, accuracy, and compliance. This evolution aligns with the concept of Validation 4.0, a modern approach that departs from traditional document-heavy methods. Validation 4.0: Digitizing and Automating Validation Validation 4.0 leverages […]
Ensuring quality and compliance is essential in medical device manufacturing, where even minor deviations can impact patient safety. This is why capability studies play a vital role. These structured evaluations offer actionable insights into how well manufacturing processes perform, helping teams maintain high standards in efficiency and reliability while meeting regulatory requirements. Yet, many manufacturers […]
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.