The new modules recognise the constantly evolving operational and regulatory requirements life sciences and medical device organisations face.
PRISYM ID today announces the addition of two new modules to its flagship solution, PRISYM 360, to further transform global Label Lifecycle Management in the clinical trials and medical device industries.
The addition of these new, innovative modules comes in recognition of the ever-evolving operational and regulatory requirements life sciences and medical device organizations face. Each addresses specific data management and workflow needs to help ensure operational efficiency in the face of ever more complex global compliance demands.
The requirements for clinical trials and medical device labels vary between countries and regulators. Ensuring that labels are compliant with regulations when they are designed, and when they are approved, is usually a manual activity; both labor intensive and inherent with risk. By defining regulatory data requirements as label design ‘rules’, conformance to these can be tested at both the label design and label approval phases of the new Regulatory Rules Module.
In addition, in an effort to improve pharmaceutical drug quality and safety, regulators are requiring clinical studies to be more extensive and to include more countries. By providing out-of-the-box clinical labeling data structures and tools based on clinical study best practice, clinical research teams can design and print compliant labels quickly and effectively using PRISYM 360’s Clinical Trial Management Module.
Unlike traditional label design tools, PRISYM 360 is an enterprise-class solution designed specifically for, and in partnership with, the life science and medical device industry.
PRISYM 360 allows companies to mitigate the costly risk of product recalls, expedite local language labeling on demand and take control of label data across the enterprise. The latest modules bring flexibility to business models and their processes, whilst minimizing IT platforms, expansion and support costs.
PRISYM 360 ensures compliance with global regulations, including the FDA’s 21 CFR regulations for labeling of medical devices and drugs, such as Electronic Records and Electronic Signatures (ERES), and increases quality and consistency in design and print of medical device and clinical trials labels. PRISYM 360 utilises the latest technology standards and is 100% browser-based.
Simon Jones, VP Global Product at PRISYM ID, explains: “The introduction of these innovative modules for the PRISYM 360 platform demonstrates the benefit to customers of our focus on life sciences labeling. Complex, changing regulatory requirements for clinical trial and medical device labeling remain a challenge in an industry which is rapidly globalizing. These unique tools address this challenge; they reduce the risk of label errors whilst helping to streamline production workflows.”