Open Text, compañía desarrolladora de Livelink, solución de gestión documental, ha anunciado que la próxima primavera lanzará al mercado una solución específicamente diseñada para la gestión de los complejos procesos de producción, aprobación y archivo de los documento relacionados con la producción de los productos médicos o farmacéuticos que requieren de pruebas clínicas en humanos.

Livelink for Collaborative Submissions, nombre con el que se ha bautizado ya a esta nueva aplicación, incluirá herramientas para el intercambio de información con las autoridades administrativas pertinentes y para la gestión y registro de los cambios realizados en los miles de páginas que han de ser sometidas a las diversas aprobaciones.

El sometimiento por ley a estas aprobaciones por parte de las agencias reguladoras obliga a las empresas farmacéuticas a mantener idénticos repositorios de los documentos durante todo el proceso. El principal reto y complejidad del proceso de los documentos en estos casos consiste en gestionar los continuos cambios realizados y sincronizarlos con los revisados y aprobados por las agencias reguladoras.

Más información en la siguiente nota de prensa en inglés.

Open Text Corporation, provider of Livelink, the collaboration and content management software for the global enterprise, said today it is introducing a new solution that gives life sciences companies a single, unified environment for managing the complex process of assembling, approving, releasing and archiving new drug and medical device applications required to enable human clinical trials and product marketing. Livelink for Collaborative Submissions supports the complete lifecycle of the submissions process, providing tools to exchange information with government regulators, as well as manage and track changes to millions of pages of documents from multiple submissions.
Applications for regulatory approvals in life sciences have evolved from massive paper document collections submitted all at once, to a rolling, electronic-submissions process requiring ongoing coordination with regulators. The process has grown in complexity despite attempts at simplification such as the adoption by regulators worldwide of a standard format for drug and biological product applications called the Electronic Common Technical Document or eCTD. Rolling submissions require both the regulators and the submitting company to maintain identical document repositories throughout the submission’s lifecycle. The challenge is managing changes to information within the company and re-synchronizing those changed documents with those being reviewed by regulatory authorities.

Livelink for Collaborative Submissions offers a single, end-to-end system to manage eCTD-compliant submissions to the U.S. Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulators worldwide. The solution combines document, forms and records management software, content publishing tools and the ability to automate a wide range of processes, from ad hoc to tightly sequenced workflows. Integrated tools such as check-in/out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy.

«We created Livelink for Collaborative Submissions to offer customers a single platform to manage submissions information and synchronize changes with the multiple regulatory authorities in major global markets,» said Martin Sumner-Smith, Vice President of Pharmaceutical Solutions at Open Text. «It can also manage a far wider range of submission types than any other product, and as such is the first dossier management system for all product-related submissions.»

Other key features of Livelink for Collaborative Submissions include:

Easy access to other file and content systems across the enterprise from Livelink to retrieve documents, data sets and other content needed in a submission.

Uniform, pre-defined taxonomies for organizing submission documents based on the eCTD with flexible extension capabilities.

Role-based access controls that tightly regulate access rights and permissions according to the roles of participants in the creation, assembly and publishing of submission documents.

Desktop integration so users can drag-and-drop items into Livelink directly from the Windows desktop in online or offline mode, using Microsoft Office, Adobe Acrobat, Windows Explorer, and WebDAV-compliant applications.

The necessary controls to be deployed as a ‘closed system’ available over the Internet for secure, convenient access by traveling staff, partners and research physicians.

Livelink for Collaborative Submissions also complies with laws such as the FDA’s 21 CFR Part 11 rules for electronic submissions. The product is being deployed in pilot customer sites and will be released in Spring 2004.

For more information on the product, go to:– submissions.html

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