Loftware Cloud Clinical Trials

Loftware Cloud Clinical Trials (previously named Loftware 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.

Features

• **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 The cost of stock overage and the risk of labels with out-of-date expiration and dosage information is significant.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.