What is regulatory submission documentation management for Life Sciences
Streamlining the regulatory submission process is essential to getting products to market faster. It is critical to create, review and maintain essential submission-related documentation appropriately and securely, even as regulatory rules and requirements vary by country and region and evolve over time.
OpenText Documentum for Research and Development features
Fast, efficient authoring
Create submission-ready documentation with approved and compliant templates. Quickly find submission-related documentation using faceted navigation and jumpstart authoring with predefined inheritance rules to re-use existing content and metadata.
Industry-standard document taxonomies
Reduce deployment time and ensure adherence to industry standards with comprehensive, predefined document taxonomies based on extended DIA EDM reference model and industry best practices for pharmaceutical and medical device products. Utilize extensive object model to effectively index, find and share documents across the enterprise.
Native collaborative editing
Allow multiple contributors to co-author documents, view a consolidated copy of all previous edits and, simultaneously, make their own changes using the standard “track changes” functionality of MS Word. Automatically merge all edits into a single document to accept, reject and review changes on a rolling basis.
Leverage access control, detailed audit trails, e-approvals and e-signatures to easily demonstrate compliance. Answer questions about progress and readiness with "where used" reports and gain insight on day to day performance of applications around the globe.
Link content throughout drug lifecycle
Link and share content from clinical, regulatory and quality to make it easy to quickly search, identify and retrieve submission-ready content. No manual intervention is required to share documents from the development phase to commercialization to support full product lifecycle.
Multiple deployment options
Choose the deployment model, cloud, managed services or on-premises, that makes sense for the organization, while ensuring security, privacy and control requirements are met.
Benefits of OpenText Documentum for Research and Development
Accelerate submission content readiness
Predefined, yet flexible, business rules allow users to quickly create and promote content to a submission ready state.
Centralize corporate document control and visibility, while enhancing local productivity with unified document creation, approval, change control, retrieval and maintain flexibility in workflows and document lifecycles.
Minimize compliance risk
Reduce noncompliance risk by automating and enforcing the appropriate approval process with automatic assignments. Demonstrate compliance through extensive audit trails, access control, lifecycle management and version control.
Seamless content sharing and re-use
Share and re-use regulated content across the extended Life Sciences organization, without importing and exporting content from one system to another, with common object model and intelligent automation of clinical, regulatory and quality content and processes.
Contact us to speak with a member of the Life Sciences team
- Documentum for Research and Development data sheet
- A path to excellence in the global regulatory submissions process white paper