Almac Group, the global contract pharmaceutical development and manufacturing organization, has launched TempEZ—a temperature management software—and the inaugural offering from Almac’s “Next Generation Temperature Management Portfolio.” TempEZ is a web-based platform providing clients with a single database to store temperature data and to ensure regulatory compliance, thereby safeguarding the quality and integrity of drug product.
The superior, Good Distribution Practice (GDP) compliant solution has been designed by Almac’s global in-house temperature management experts who have over 25 years’ experience in the field. Their deep insight into the challenges faced by their clients has enabled TempEZ to be shaped to provide the most flexible, convenient and secure platform available on the market. This offering guarantees complete visibility of any commercial or clinical drug product’s temperature compliance throughout its entire journey from manufacture to patient administration, and crucially, not just transit.
The TempEZ design enables the client to use any monitor and any logistics provider for managing transportation of their product to its final destination. The GMP compliant software provides readily accessible data throughout the entire supply chain building a complete temperature history for a product at both a lot and serialized level.
By leveraging Almac’s extensive experience with medical products and as a logistics provider, clients can also benefit from the additional supporting Temperature Management services offered to supplement their own internal efforts. Almac’s global Temperature Management team perform compliance, excursion adjudication and life cycle management services. In addition, their Temperature experts will interpret the data collected by TempEZ and assist clients to develop bespoke solutions to improve their internal business processes and vendor performance.
“Almac’s TempEZ is the only software platform available on the market that offers clients a tailored, fully adaptable and GDP compliant solution providing a complete, end-to-end temperature history of their drug product,” said Donna Christopher, global vice president, Operations, Almac Clinical Services. “In the current data model clients have difficulty accessing and analyzing data to determine the impact of individual excursions occurring throughout the life cycle on the overall integrity of the product. By design, TempEZ gives any stakeholder in your supply chain the ability to upload data, resulting in a single repository of your temperature data. This makes the data readily accessible and any analysis easy to complete.”