The new modules recognise the constantly evolving operational and regulatory requirements life sciences and medical device organisations face. Each module addresses specific data management and workflow needs to help ensure operation efficiency in the face of complex global compliance demands.
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Requirements for clinical trials and medical device labels vary between countries and regulators. Labels must be ensured to be compliant with regulations when they are designed and when they are approved.
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 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 labelling 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.
PRISYM 360 is an enterprise-class solution designed specifically for, and in partnership with, the life science and medical device industry. The solution allows companies to mitigate the costly risk of product recalls, expedite local language labelling on demand and take control of label data across the enterprise.
PRISYM 360 ensures compliance with global regulations, including the FDA’s 21 CFR regulations for labelling 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.
Simon Jones, VP Global Product at PRISYM ID, said, “The introduction of these innovative modules for the PRISYM 360 platform demonstrates the benefit to customers of our focus on life sciences labelling. Complex, changing regulatory requirements for clinical trial and medical device labelling remain a challenge in an industry which is rapidly globalising. These unique tools address this challenge; they reduce the risk of label errors whilst helping to streamline production workflows.”