This blog post will summarize Documentum’s D2 solutions for the life sciences industry. There was one presentation at 11:30 covering the currently released solutions and one at 2:30 covering the solutions that are upcoming.
Tuesday @ 11:30 – Life Sciences: Compliance, Productivity and Secure Collaboration
Tuesday @ 2:30 – Life Sciences: What’s New & Next – EMC Documentum Life Sciences Solution Suite Roadmap
Life Sciences D2 solutions
- Quality and Manufacturing Solution (Q&M)
- originally released in May/June 2012
- Q&M 2.0 to be released in the next few weeks
- Electronic Trail Master File (eTMF)
- 2.0 to be released in the next few weeks
- Submissions D2 Solutions
- Coming Later this year
- R&D D2 Solution
- Coming later this year
D2 Solutions Built with Interoperability Layer
EMC is building a D2 Life Sciences interoperability Layer that contains common functionality that will be used across all D2 life sciences solutions. This interoperability layer.
- Utilizes the DIA and TMF reference models.
- Contains a predefined set of roles
- Includes Part 11 Compliance (Utilizes C2 overlays)
- Predefined Lifecycles
- Other ECM Controls – didn’t elaborate on what this was (I assume versioning starting at 0.1, etc.)
- Integrations – Presenter didn’t elaborate
The presenter talked about how all of these D2 solutions can co-exist on one repository and would allow content from these different applications to all reside in one repository. From our experience I wonder if this is a realistic proposal. Typically clients segregate their content based on solution (Submissions, Quality Documents, etc.).
eTMF Solution Highlights
- Can set up trail template that you specify which artifacts are required or optional for each study (phase 1 trial has different requirements than phase 3 trail)
- Use MS Excel to create template (can be specific based on product, trial, country and site) – creates place holder documents.
- When you update the document in D2, the excel file is auto updated to show the status. (D2 to Excel connector)
- Default auto filing and auto naming rules for artifacts
- Can manage documents across 5 stages
- Role-based views (Trial Managers, Clinical Trial Librarians, clinical Investigators, others)
- Support for Trial Locking – soft and hard
- Soft Lock – Users can import, but not make documents effective
- Hard Lock – no new content can be injested
- Web services available to integrate to CTMS apps, etc.
Q&M Solution Highlights
- Only configurations in D2 were done to create this solution. No coding.
- Roles – Authors, coordinators, reviewers, approvers, auditors, etc.
- Can set up projects (product related, or site related). Approvers can be automatically applied if a document is assigned to a specific project
- eSigs and Overlays (from C2 product)
- eSignatures can be done from a mobile device
- Solution comes with default Word templates
- Contains the ability for fields in Word (title, Document Number, etc.) will feed the Documentum Properties and therefore the Overlays.
- 4 available Lifecycles. Documents are assigned to one of the lifecycles below.
- GMP – for review, for approved (QA and other signature required, Pending Release, effective)
- Review & Approval – Similar to GMP, No QA approval required
- Self Approval
- Users with documents marked as “to be read” receive a workflow task to sign off and state that they read and understood the document.
Other Solutions Coming Soon by end of 2013
- No detail provided regarding features of this solution
- Submission Management
- Link of approved documents to dossier based on predefined template
- Vesion control of dossier
- Review and approval of dossier itself
- Change Mgmt including eCTD sequences (amendments, supplements, etc.)
- Mgmt of Shared Docs (same docs can be linked to multiple submissions)
- Submission planning & Tracking (due dates, overdue notifications)
- Submissions correspondence (Track responses, etc.)
- Can use with other submission publishing tools
- Submission Publishing
- Supports publishing export & review of dossier (eCTD, NEES and paper formats)
- Supports regional M1 modules and Study Tagging files (STFs)
- Manages submission sequences through intuitive graphical web interface
- Cross-references (hyperlinks) support and maintenance
- Supports the full lifecycle of your electronic submissions
- No need to export docs. To 3rd party or file system to publish eCTD
- Partners to develop other solutions
- Clinical Investigator Portal
- SaaS upate; xCP based client
- List of to-do Items
- Tracking of Trail Stage (need to complete 5 items to get passed enrollment)
- Looking for companies to assist with validating the use cases
- Seriously Considering Development of the following solutions
- Drug Safety
- Medical Device
- Promotional Materials
- Call Center
Other Items Mentioned
- EMC Documentum On-Demand offering.
- EMC engineers can install, maintain, generate validation documentation within your data center or within EMC data center.
- Syncplicity Use Cases for Life Sciences
- Q&M – distribution of SOPs to manufacturing floor so they can easily find the subset of SOPs that they need (I tend to think a simple offline search and retrieval app like HPI would work better for this use case)
- eTMF – drop documents to auditors
- Note if using Syncplicity, overlays are not dynamically added (they are burned on when document is sent to Syncplicity
- Documents are not dynamically updated on Syncplicity. if the document is updated in the repository it must be pushed out to Syncplicity again.
EMC has definitely shown a re-commitment to their original customer base. There is an entire track at EMC World dedicated to Life Sciences. The D2 solution sounds intriguing, but we still feel have some hesitancy for the following reasons:
- When asked about clients in production, exact numbers were not disclosed. But it is our understanding that there are no life science clients currently in production.
- Cost – This feels like an expensive solution. D2 license cost + D2 solution costs + Migration Costs – all of which can only be done with Documentum Consulting
- For better and worse clients have customized Webtop and other slutions. to meet their individual needs. We struggle with mature clients paying the convesion costs and “giving up functionality” for a new release. While I am sure many of these customizations can be removed with configuration settings , I would wonder what flexibility am I giving up moving to an architecture that doesn’t allow for any flexibility outside of the designed framework and is worth the considerable effort and cost to get there.
- Crowded Market for Some Solutions – Some of these solutions are in already crowded markets. We would recommend waiting to see how these solutions are adopted before jumping on board
Please let us know your thoughts below.