HOPKINTON, Mass., Oct. 24, 2016 /PRNewswire/ --
- Suite, which includes four complementary solutions – electronic trial master file (eTMF), research and development (R&D), submission store and view, and quality and manufacturing (Q&M) –supports organizations with combined pharmaceutical and medical device offerings
- Provides Clinical, Regulatory, and Design History File/Device Master Record document enhancements for full lifecycle support, from design to production manufacturing
- Increases usability and exceeds good practice regulatory requirements when managing controlled paper copies
- Extends eTMF capabilities for more granular insight, and provides quality control features and new dashboard metrics to ensure optimal quality of trials
- Delivers simultaneous eTMF support for both the 2.0 and 3.0 DIA eTMF Reference Models
- Offers an expanded R&D inventory to help speed regional regulatory submissions and ensure alignment with regulatory guidance
Dell EMC™ Enterprise Content Division (ECD), a leader in the enterprise content management industry, today announced the general availability of EMC® Documentum® for Life Science, which now includes new capabilities for supporting medical device documentation in addition to pharmaceutical documentation. The latest version focuses on driving efficiency, enhancing usability and improving visibility and insight across clinical, regulatory and quality solutions. Enhancements include the addition of a harmonized medical device solution, expanded best practices R&D inventory, support for multiple DIA eTMF reference models, an enhanced, flexible controlled print model and increased capabilities for the eTMF solution.
"Life Science organizations are leveraging enterprise content management as part of a holistic strategy that embraces a broader organizational approach to transformation," said Dr. Alan Louie, PhD., Research Director, IDC Health Insights. "The Dell EMC Documentum for Life Sciences solution is well aligned with this market opportunity, providing harmonized data models and document inventories and processes across the clinical, regulatory and quality domains."
"Many Life Science organizations have difficulty implementing a cohesive solution for both pharmaceutical and medical device documentation, since available systems are often too complex or cost-prohibitive for smaller businesses," said Andy Crowne, Vice President of Industry Solutions and InfoArchive. "EMC Documentum for Life Sciences solution suite brings both options together in a single repository, giving companies of all sizes the choice and flexibility of implementing a single medical device solution or deploying R&D and Q&M independently to align with business functional areas."
The Dell EMC Documentum for Life Sciences solution suite is designed to break down information silos to transform how organizations access, manage and share regulated content. The solution provides a single source of accurate, complete, and compliant information that reduces risk and helps bring high quality, safe products to market faster and at a lower cost.
Support for Medical Device Documentation
Due to a lack of both global, harmonized industry standards for medical device documentation and requirements for electronic submissions (with XML data) by governing agencies, few vendors provide out-of-the-box documentation support for medical device management. As a result, companies often must deal with the limitations that come with paper-based systems, including process inefficiency and a lack of traceability and control.
Dell EMC Documentum for Life Sciences provides a cohesive solution that manages quality and regulatory documentation for both medical devices and pharmaceuticals. It supplies a global, standard document inventory and processes across regulatory and manufacturing, enabling a complete, standard framework for creating and managing global medical device documentation.
Expanded Best Practices to Support Quality, Clinical Trial, and Regulatory Documents
Many organizations struggle with document classification challenges brought on by their Life Science solutions' inability to produce complete taxonomies, support a hierarchical organization structure and manage multiple classifications. With Dell EMC Documentum for Life Sciences, customers can implement full turnkey solutions that include an expanded R&D inventory beyond the DIA Reference Model to better support global quality, clinical trial, and regulatory document types in all regions that are current with the latest industry standards. The solution also supports both eTMF DIA Reference Model versions 2.0 and 3.0, ensuring legacy documentation is supported and eliminating the need for complex migrations.
Flexible Print Controls to Maximize Efficiency and Ensure Compliance
Paper documents are still prevalent in manufacturing environments despite the ever increasing use of mobile devices. Existing print methods are typically compliant but are not flexible or user friendly. The Dell EMC Life Sciences solution enables users in these environments to meet compliance requirements while increasing flexibility and improving usability, including the ability to specify document types, document status and desired print profile for controlled printing to both internal and external recipients, all while ensuring that controlled copies contain required watermarking and overlays.
eTMF Enhancements for Planning, Insight and Improved Quality
Dell EMC Documentum for Life Sciences powers eTMF enhancements that enable granular planning, improve eTMF quality and usability, and provide actionable insight. These advancements, which help eliminate the difficulty in applying business rules and managing eTMF documentation requirements, along with the inability for clinical trial managers to add these trial management rules that may differ based on trial type and location, include:
- Country- and site-level milestones, allowing progress of document collection to be tracked at different times based on the location of the study
- Enhanced Quality Check to better ensure documentation compliance
- Improved usability working with expected document placeholders, making it easier to find, identify and upload missing documents
- Mandatory or optional specific property settings at the artifact level, creating automatic user prompts for entry to ensure accuracy and completeness.
- Learn more about Dell EMC Documentum for Life Sciences on EMC.com
- Learn more about the Enterprise Content Division leadership team
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