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.
Simplifique las revisiones y las aprobaciones de las etiquetas La información que acompaña a los ensayos clínicos es esencial para garantizar un uso seguro y eficaz. Una solución optimizada puede ayudar a administrar y diseñar fácilmente el contenido de las etiquetas, los prospectos y el empaquetado.
Habilite nuevos modelos de la cadena de suministro. El coste del exceso de existencias y el riesgo de las etiquetas sin fecha de vencimiento e información sobre las dosis no es nada desdeñable. La generación dinámica de etiquetas ofrece eficiencia, velocidad y agilidad para permitir modelos de impresión y embalaje Just In Time (JIT, justo a tiempo).
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.
El software Loftware Cloud Clinical Trials ha simplificado el etiquetado regulado para el sector de los ensayos clínicos. Una etiqueta no es solo el texto y las imágenes que vemos, sino también la compleja estructura de contenidos y datos que se encuentra debajo. Desde el texto variable hasta los requisitos específicos de cada país y obligatorios a efectos del cumplimiento normativo, es importante hasta el último detalle.
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.
