Blog
March 18, 2024 || Connie Leech
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves on the road to recovery. The COVID-19 pandemic exposed vulnerabilities and challenges in pharmaceutical supply chains, leading to drug shortages and disruptions. While some aspects…
March 18, 2024 || Connie Leech
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical products, thereby enhancing patient outcomes and overall satisfaction. Manufacturers can consistently deliver sterile medications and devices by employing state-of-the-art aseptic processing techniques, reducing the risk…
March 18, 2024 || Brian Stephens
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects that used the FDA’s draft of the Computer Software Assurance for Production and Quality System Software Guidance (CSA). The number of resources, the amount of…
March 18, 2024 || Kevin Hawkins
This is the final installment of a three-part series exploring the transformative power of Virtual Twins as part of an asset induction effort for facility maintenance. The information in this series is based on the use of Virtual Twin technology for a biomanufacturing site, but the same principles could be…
March 18, 2024 || Kevin Hawkins
This is the second installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. Part One of this series provided an overview of implementation of this technology and benefits once completed. Now, in Part Two we will address…
March 18, 2024 || Kevin Hawkins
This is the first installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility maintenance. The information in this series is based on the use of Virtual Twin technology for a biomanufacturing site, but the same principles could be…
February 23, 2024 || Mark Burlingham
Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure to managing resources and ensuring a comfortable environment for employees. Below are five key areas where organizations commonly have room to improve their Facilities Management…
February 12, 2024 || Brian Stephens
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer Software Assurance guidance in September 2022. Since that time, I have used this guidance to reduce the effort and cost required to complete two large…
February 9, 2024 || Emily Purchase
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has updated its guidance on remote regulatory assessments (RRAs), emphasizing that they differ from inspections and outlining new powers granted by a recent spending bill. The…
February 9, 2024 || Joe Leuser
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of full-scale range and use a tolerance of 1.5 or 2 times the manufacturers’ tolerance. Many companies standardize frequencies to calibrate all critical instruments every six…