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.
ラベルのレビューと承認を簡素化します。治験に付随する情報は、安全かつ効果的な治験薬の使用を保証するために不可欠です。合理化されたソリューションにより、ラベルのコンテンツ、添付文書、パッケージングを簡単に管理、設計することができます。
新しいサプライチェーン モデルを可能にします。在庫超過のコストや、有効期限や用法用量の情報が古いラベルのリスクは重大です。動的なラベル生成は、ジャストインタイム（JIT）印刷やパッケージングモデルを可能にする効率性、スピード、アジリティを提供します。
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 ソフトウェアは、治験環境で規制されているラベリングを簡素化します。ラベルは、単なる文字や画像ではなく、その下にあるコンテンツやデータの複雑な構造です。可変テキストから国別要件、規制遵守に至るまで、細部に至るまで重要な事項が詰まっているのです。
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.
