Automated Storage and Retrieval Systems (ASRS) are becoming increasingly common across pharmaceutical, biotechnology, and medical device manufacturing and distribution environments. As organizations scale operations, improve efficiency, and support higher product volumes, ASRS offers clear operational advantages. However, automation does not reduce validation responsibility. In regulated life sciences environments, ASRS introduces new validation, compliance, and data integrity considerations […]
Computer Software Assurance (CSA) Resource Series – Article 1 of 5 Software plays a larger role in medical device manufacturing today than ever before. From production equipment and environmental monitoring systems to quality management systems, electronic records, inspection technologies, and analytics platforms, manufacturers rely on software to support nearly every aspect of production and quality. As technology […]
Starting with Curiosity—and a Leap into the Unknown Like many early-career engineers, Alison didn’t begin with a background in pharmaceutical validation. With a mechanical engineering degree and experience in fluid systems and consumer products, the validation field was entirely new to her. What drew her to PV wasn’t technical familiarity—it was trust and culture. A […]
As pharmaceutical supply chains grow more complex, third-party logistics providers (3PLs) are playing an increasingly critical role in product quality and patient safety. Temperature-controlled storage and distribution is no longer viewed as a downstream operational function. It is an extension of the manufacturer’s quality system. For 3PLs, this shift has introduced new expectations, greater scrutiny, and increased involvement in […]
Validation teams today face growing pressure from multiple directions. As organizations evaluate the benefits of digital validation, product timelines are tighter, regulatory expectations are more explicit, and teams are often distributed across sites and time zones. At the same time, traditional validation approaches remain heavily document driven, manual, and resource intensive. Digital validation addresses these challenges by transforming how […]
In sterile pharmaceutical manufacturing, visual inspection validation is a critical step to ensure that a batch of product is essentially free of sources of contamination and ready for release for patient use. While it may seem routine, this stage plays a vital role in protecting patient safety, ensuring product quality, and satisfying regulatory expectations. A […]
Automated Storage and Retrieval Systems (ASRS) are becoming increasingly common across pharmaceutical, biotechnology, and medical device manufacturing and distribution environments. As organizations scale operations, improve efficiency, and support higher product volumes, ASRS offers clear operational advantages. However, automation does not reduce validation responsibility. In regulated life sciences environments, ASRS introduces new validation, compliance, and data […]
Pharmaceutical manufacturing facilities are under more pressure than ever. Timelines are tighter, regulatory expectations are higher, and the cost of a delayed startup or a failed inspection has never been steeper. In that environment, the CQV engineers responsible for correctly qualifying and validating systems aren’t just project resources. They’re a risk management function. For many […]
If your facility has ever faced a delayed product launch, a failed regulatory inspection, or a costly batch rejection, there is a good chance the root cause traced back to gaps in CQV. With this practical guide, you can build a CQV program that holds up when it matters most. CQV stands for Commissioning, Qualification, […]
Performance Validation (PV) is a 100% employee-owned company. What does that really mean? Many companies talk about culture, collaboration, and teamwork. But an employee-owned company, specifically an ESOP (Employee Stock Ownership Plan), creates different relationship between employees and the organization. Ownership changes how people think, how decisions are made, and how success is shared. At […]
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.
