A lot has happened in the Life Sciences industry since the last update to OpenText™ Documentum for Life Sciences in 2018. Regulatory changes, such as the European Union (EU) Clinical Trials Regulation 536/2014 is introducing fundamental changes to the submission process for Phase I to IV interventional clinical trials. And while there has since been a delay in the rollout of the Identification of Medicinal Products (IDMP) regulatory framework, it’s there on the horizon.
At OpenText, our job is to help companies deal with changes like this by continuously improving our offerings. Our ultimate goal is to help you get products to market faster by increasing efficiency, usability, and the productivity of your professional team. It’s that simple.
By way of introduction, OpenText™ Documentum™ for Life Sciences comprises four solutions covering the complete drug-development lifecycle: clinical, research and development (R&D), regulatory submissions archive, and quality and manufacturing. By breaking down information silos across these domains, these solutions transform your approach to accessing, managing, and sharing regulated content. A unified solution layer provides a consistent data model, common business rules, and the ability to seamlessly share content between them.
Thanks to our customers’ invaluable input, we have made significant improvements with OpenText Documentum for Life Sciences EP6. Here’s the roundup.
Connect the enterprise
OpenText Documentum for Life Sciences EP6 is now seamlessly integrated with Office 365/SharePoint – a big leap forward in usability. Now your team can collaborate on documents in real time with both internal and third-party colleagues. They have the flexibility to use Word track-changes features, and to edit collaboratively in SharePoint, even viewing changes as others are typing, if they prefer. This new functionality is important to support co-authoring, particularly when dealing with complex documents with multiple collaborators. Configured workflows automate the collaboration process. When initiated, users can post content to SharePoint and, upon completion, automatically pull documents with consolidated changes into the controlled repository.
There are two key improvements that will go a long way toward streamlining document management. First, authorized users can reclassify content and metadata due to errors or when original and target classification conflict. (Original properties are preserved for compliance purposes). Second, a bulk-property update allows a user with permissions to change multiple properties on multiple documents at once (but still generating a report of changes that require approval before the changes take effect). The result: higher-quality content and metadata, and assurance that documents do not need to be re-approved after the update.
Now, multiple documents can be managed with single actions, including bulk-import of externally approved documents into final state – an improvement that met with loud applause from delighted users during a recent customer meeting! One-click batch processing eliminates the need for repetitive steps and adds efficiency in daily work. The ability to import documents into final state removes the unnecessary extra work to approved documents finalized elsewhere.