Ennov, a leading provider of innovative software solutions for the Life Sciences industry is pleased to announce the release of Version 8.6 of our unified compliance platform. The release includes many new features and functions including enhancements to Ennov Doc, Ennov Process, Ennov Dossier and Ennov RIM. The most significant new feature is the addition of a comprehensive XEVMPD module to manage all data and documentation (attachments) required to generate compliant XEVPRM messages, submit via the gateway and manage acknowledgements.
Ennov extended the Ennov RIM data model to include the majority of XEVMPD-related information (including XEVMPD compliant controlled vocabularies) while some submission-related information is managed by XEVMPD specific objects.
Within Ennov RIM, the XEVMPD submission process manages the preparation, submission and responses from EMA for XEVMPD messages, containing information for XEVMPD Authorized Products and/or XEVMPD Organizations. The XEVMPD submissions can be either created manually or generated automatically via workflow from a regulatory activity such as a variation or renewal.
“The new XEVMPD functionality in Version 8.6 will have a significant impact on our customer’s operational performance” says Ennov Product Line Director James Deleuse. “Now they will be able to manage all required XEVMPD information and submit directly to EMA using Ennov RIM– eliminating the need to re-enter the data via EVWEB.”
To learn more about Ennov and our innovative regulatory solution suite, visit www.ennov.com.
Headquartered in Paris, with offices in the US and UK, Ennov provides the most intuitive, comprehensive, and cost-effective suite of software solutions for the life sciences industry. From leading pharmaceutical companies to emerging biotechnology companies, we proudly serve over 200 companies and 150,000 users around the world. Our solutions are designed and built to support the entire Life Sciences R&D continuum including Clinical, Regulatory, Quality, Pharmacovigilance and Commercial.