Loftware Cloud Clinical Trials (previously Loftware Prisym 360) streamlines clinical supplies labeling and content management – it’s built into our software’s DNA. Our solution removes costly unknowns by simplifying complexities and shortening timelines to deliver GxP-compliant labeling with consistency, accuracy, and speed.
简化标签审核和批准。伴随临床试验的信息对于确保安全和有效使用至关重要。简化的解决方案可以帮助您轻松管理和设计标签内容、插页和包装。
启用新的供应链模式。库存过剩带来的成本，标签上的失效和剂量信息错误，这两者都会带来重大风险。通过生成动态标签，可以提供效率、速度和敏捷性，以实现 JIT 打印和包装模型。
Keey running smoothly by moving 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.
Make connections by integrating 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.
Skip the worries by having full visibility. 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.
Manage the complexity and 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.
Loftware Cloud Clinical Trials 软件优化了临床试验领域受监管的标签作业。标签不仅仅是文本和图像，其下方更有着复杂的内容和数据结构。从变量文本到特定国家的要求和监管合规性，每个细节都很重要。
But at Loftware, we pride ourselves on knowing these intricacies in product identification. 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 remove costly unknowns by getting trials to market quicker and more cost effectively, allowing you to do what you do best… delivering patients a safe, positive, and effective trial outcome.
Connect with our specialists to explore Loftware Cloud Clinical Trials.
