For Clinical Trials
Loftware Prisym 360 for clinical trials
Prisym 360 streamlines clinical supplies labeling – it’s built into our software’s DNA. Our solution simplifies complexities and shortens timelines to deliver GxP-compliant labeling with consistency, accuracy, and speed.
The proven solution for clinical trial supplies labeling
Enable regulatory compliance
Simplify label reviews and approvals. Information that accompanies clinical trials is essential in ensuring the safe and effective use. A streamlined solution can help you manage and design label content, inserts and packaging with ease.
Improve response times
Enable new supply chain models. The cost of stock overage and the risk of labels with out-of-date expiration and dosage information is significant. Dynamic label generation offers efficiency, speed, and agility to enable Just In Time (JIT) printing and packaging models.
Simplify label and booklet design
Move beyond manual processes. Each country has their own regulatory and language requirements, however, you can automate processes to reduce clinical label and booklet design and printing from weeks to hours, while ensuring regulatory requirements are met and removing errors.
Drive continuous improvement
Integrate with critical systems such as Clinical Supply Management (CSM), Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM), and other data repository systems to retrieve the most up-to-date label data at the point of printing, providing accuracy and consistency.
Centralize control for traceability
Visibility offers true benefits. Maintain complete integrity of your label data to meet compliance with FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820. Enabling a view of master data assets provides the ability to control, optimize and help ensure compliance.
Support global requirements
Avoid risk of error. As the number of countries included in each study increases, so does the need to meet specific regulatory content, phrase, and language requirements. Having an automated solution helps to reduce timescales and prevent errors.
Providing a labeling solution for effective clinical trials
Prisym 360 software has simplified regulated labeling for the clinical trial landscape. A label is not just text and images, it’s a complex structure of content and data that lays beneath. From variable text to country specific requirements and regulatory compliance, every detail matters.
But at Loftware, we pride ourselves on knowing these intricacies. That’s our business. To provide you with a validation ready cloud-based labeling solution that’s simple, agile, and scalable. We enable you to get trials to market quicker and more cost effectively, while allowing you to do what you do best… delivering patients a safe, positive, and effective trial outcome.
Powerful capabilities of Prisym 360
Don't take our word for it. See what others are saying.
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