| Ideal for | Built to |
|---|---|
| Pharmaceutical companies Contract development companies Regulatory operations |
Ensure all documents are submission-ready Streamline submission document review and approval Improve author productivity for submissions |
Accelerate the creation, review, and approval of regulatory submission documentation with the OpenText Research and Development solution. To ensure adherence to industry standards and improve overall productivity, our solution provides predefined taxonomies and business process rules.
IMPROVE DOCUMENT ACCURACY
The Research and Development solution enables organizations to eliminate redundant data entry and improve the accuracy of submission documentation. It leverages out-of-the-box, industry-standard dictionaries and taxonomies of the Drug Information Association (DIA) Electronic Document Management (EDM) reference model.
STREAMLINE REVIEW PROCESS
Allow multiple contributors to make edits and annotations to documents simultaneously, with the solution automatically merging all edits into a single document. Streamline the authoring process with automated workflows, shortening the time for reviews and approvals.
INCREASE AUTHOR PRODUCTIVITY
Eliminate authors? need to manually select and create documents by enabling them to select from a predefined inventory of reusable, industry-standard documents that are automatically linked with the associated document types required for a submission.
MINIMIZE COMPLIANCE RISK
Reduce noncompliance risk by automating and enforcing appropriate approval processes. Our solution automatically assigns review and approval workflows based on predefined rules and routes documents to appropriate staff, based on document type.
