Advanced Aseptic Processing starts with the facility: To assure safety and efficacy of the medicines many rely on, the manufacturers must embrace advanced aseptic processing. To the regular person, this might sound like a fancy buzz phrase but to those in the industry and those creating the powerful therapeutics that patients rely on, this is a […]
In the pursuit of sustainable building design, LEED (Leadership in Energy and Environmental Design) certification stands as the pinnacle of excellence. Among the many credits available within the LEED certification process, enhanced commissioning is one of the credits with the most value-add, particularly in Washington state. Today we will be exploring the significance of LEED […]
In the rapidly evolving pharmaceutical and medical device industries, transitioning to paperless validation is becoming increasingly vital. This shift not only streamlines processes but also enhances data integrity and compliance. Here, we explore the key benefits of adopting paperless validation. What is Paperless Validation? Paperless validation refers to the use of digital tools and systems […]
As Washington state continues committing to sustainability and environmental stewardship, the implementation of the Washington Clean Building Standard has become a focal point for building owners and developers. For those embarking on new construction projects, incorporating commissioning requirements that align with the standard is essential to achieving compliance and optimizing building performance. We will be […]
Performance Validation, Inc. (PV) is thrilled to announce that Robert Perks has joined our team as the new Digital Solutions Director. This strategic addition to our team will significantly enhance our Automation and CSV services, including IT and OT CSV, Process Automation, Paperless Validation, and Digital Transformation initiatives. Robert’s extensive experience and expertise will undoubtedly […]
With the summer season on the horizon, pharmaceutical companies face the annual challenge of ensuring their temperature-sensitive products remain within specified conditions despite the heat. Temperature fluctuations during this time can significantly impact product integrity, efficacy, and safety. This blog provides a comprehensive guide on preparing your temperature mapping for the summer, including best practices […]
For building owners seeking to optimize energy efficiency and reduce operational costs, conducting an ASHRAE Level II Energy Audit can provide instrumental insights and recommendations. Today we will discover what a typical ASHRAE Level II Energy Audit entails, including the key components, methodologies, and potential outcomes for your building. An ASHRAE Level II Energy Audit […]
In the building commissioning process, there is a pivotal document that often gets overlooked however it serves as the cornerstone for project success: the Owner’s Project Requirements (OPR). Despite its significance, the OPR is frequently underestimated or misunderstood. In today’s blog we will explore why the Owner’s Project Requirements are the unsung hero of a […]
Automated Storage and Retrieval Systems (AS/RS) have revolutionized the landscape of material handling and storage, offering unprecedented efficiency and space optimization. However, the path to a seamlessly integrated AS/RS in a facility is fraught with challenges, especially during the validation phase. This critical stage is where theoretical designs and simulations confront the tangible realities of […]
In pharmaceutical and medical device manufacturing, the concepts of Commissioning, Qualification, and Validation (CQV) form the backbone of ensuring that equipment, systems, and processes operate as intended, consistently producing high-quality products. These activities are not just operational necessities; they are stringent regulatory requirements designed to safeguard patient safety. With a landscape governed by international standards […]
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.