We wanted to thank Rich Medina from Doculabs for a nice mention of our Complaince Solution/HPI in his post on How to select a Life Sciences Document Management Solution. We agree with Rich that “the emergence of non-Documentum options as serious candidates to manage controlled documents in the life sciences industry” is something we are seeing more and more. This post will provide some of our thoughts on the Life Sciences Compliance decision process and add to some of Rich’s thoughts along with links to previous relevant posts.
Document Management for Life Sciences – what are the choices?
More and more, Documentum users are looking for non-Documentum solutions to replace existing controlled document applications. We touched on the move in a general sense in our migration series but, agree with Rich that Life Sciences customers seem to be particularly anxious about considering non-Documentum alternatives. Whether it be due to cost, relationship, or expensive migration and validation efforts in the past, with the announcement by Documentum of the gradual sun setting of Webtop/DCM, existing Webtop/DCM customers will need to migrate someplace in the future. Options include:
- D2 Solutions – Documentum announced last year at EMC World (add link) that they were re-entering the Life Sciences space with both controlled document and submission solutions. D2, along with consulting services from EMC, make up the core of the new offering. During our research on D2 as well as discussions with existing Webtop/DCM customers, we see more concern than excitement for this new solution. Concerns include the additional purchase cost of D2, migration to a new object model, as well as the inability to alter D2 for any missing functionality without using Documentum Consulting.
- Alfresco – TSG has been actively promoting Alfresco as a solid and more cost effective alternative to Documentum. Our Complaince Solution for Regulated Industries (add link) has been validated by multiple life sciences companies and supports either Documentum or Alfresco. Our latest offering was developed first on Alfresco and then Documentum based on client requests.
- CSC/FirstDocs – Documentum seemed to be promoting the FirstDocs solution on Documentum when they announced the sun setting of DCM in 2009 (add link to EMC World). CSC solution offers both solutions for Documentum or SharePoint (although it is our understanding that the SharePoint option has not been widely deployed to replace Documentum at the time of this post).
- SharePoint – SharePoint 2010 got a ton of attention from customers in 2010 (related post – Documentum and SharePoint – Key differences for document control applications) but many are viewing SharePoint as less of an ECM play and more of a collaboration platform.
- Non-ECM Soutions – We have seen clients thinking about leveraging existing purchases for other systems for their ECM modules such as SAP, Matrix1 or Veeva. Typically the solutions are leveraged elsewhere at the client (SAP- Financial/Manufacturing – Veeva –CRM) . We see SharePoint here as well. The logic usually goes “Well, we have it already….might as well try to use it.”. We haven’t seen a lot of success with this strategy since most solutions lack the current Documentum ECM capabilities.
- Old Solutions – We still see Qumas occasionally although it is mostly tied to our migration efforts.
We have seen many clients struggle with the process and making these decisions. Part of our consulting practice is focused on our migration product, OpenMigrate, and we see a lot of migrations from one product/firm to another product/firm. There is no easy answer and a decision made one year can be undone/redone by a different stakeholder the next year, leaving users confused and stressed.
Where do you start? – Separating Consumers from the Authors/Approvers
We see many clients, particularly after heavy investments in Webtop, struggling with the next step. The first thing we always recommend for existing Documentum users is to separate the Consumer Application from the Author/Approvers Application. In this manner, clients can extend life of Webtop authoring while improving their user experience and reducing Documentum commitments. We have posted often on this subject and searching:
- Documentum Business Continuity – A Cached Content Approch
- Documentum Performance – Search, Retrieval and Inbox
- Documentum Searching – D2, Webtop, HPI and Xcp
- Documentum Search – How to get around the user request of “I just want a search
Typically, the majority of users only need access the PDF copy of documents once they have been approved and released. Physically separating the systems results in dramatic improvements in regards to business continuity, license costs, performance, training, and integration into other systems. Legacy Documentum applications have typically been tied real-time into other systems, including submission, training, and work order. Combined with business specific logic around author and approval, these ties to other systems add significant user cost and can make upgrading extremely complex and can potentially interrupt buesiness. By moving to a neutral consumer application, the migration/upgrade process and risk can be dramatically reduced.
This small first step that is typically well received by frustrated Webtop users. With the approach, the system developed for consumer access can be populated by the legacy Documentum system as well as the new authoring system, allowing for a gradual movement of documents/departments rather than a risky big-bang approach.
Step 2 – Separate Submission from Compliance
When Documentum emerged in the 90s, the entire focus of the company was on Life Sciences, particularly New Drug Application (NDA) submission. Their focus on submissions gave us the Virtual Document functionality that is so unique to Documentum. Since that early focus with Documentum for the Vault and Core Dossier for the submission publishing, a variety of other solutions have emerged, including cloud based alternatives. With XML and other tools, Documentum and Core Dossier no longer lead the market in regards to submission applications.
Just as separating the Consumers from Authors/Approvers simplifies the requirements process, separating submission from the ECM compliance decision further reduces the requirements and the number of participants, while improving the focus on the compliance decision.
Next Step – Compliance Author/Approver Requirements – think industry best practices
This is where we see clients traditionally struggle. Coming up with a list of requirements is very difficult and will vary between different people and groups. Trying to prioritize can often be a political and cultural nightmare as the “too many cooks spoil the soup” argument comes into play as R&D might think one type of functionality is important while Quality is focused on something else. Throw in competing priorities (reduce errors and signatures versus improve throughput), and the process can quickly become unwieldy.
This is where we differ from Rich’s Doculabs approach as we recommend clients start with a list of requirements that represent industry best practices, rather than creating the list from scratch. Most consulting firms that work in Life Sciences compliance should have a list (email us if you want ours), and can help navigate key stakeholders through the list. Stakeholders should be able to prioritize the must have, nice to have and don’t want components quickly.
Vendor Presentations – Software Product AND Consulting – It is all about TRUST
Rich’s next point is to have a bake-off among the vendors to see what the products can do now compared to the requirements. We would agree that vendor presentations to the stakeholders, who now have a solid understanding of the requirements, is the next step. The difficult part about rating the vendor alternatives is that pretty much all of the solutions mentioned are not pure-play software products and will would require or benefit from a consulting project. For example:
- New D2 Life Sciences offering from Documentum comes with consulting, and it can only be Documentum consulting.
- We have never seen a FirstDocs or Nextdocs implementation that did not include CSC or Nextdocs for consulting support.
- We, TSG, are typically involved with the majority of our clients in some type of consulting arrangement.
Why the need for consulting? Just like with the requirements gathering process, the understanding of how to implement with a reliable object model, security, lifecycle, versioning and a variety of other decisions are often too difficult for clients to handle on their own. Most of the options, like us, offer to assist clients through these decisions and implementation to have a successful implementation.
Stakeholders looking for a “knock-out” that “this product doesn’t do these requirements” will get a consulting answer of “we could make it do that, but it will cost $”. A key decision point for reviewers is to feel comfortable with the consulting offering, even more than the software itself. Key questions to ask:
- Do I trust that them that the software will evolve with us and their other clients over time?
- Do I trust that the consultants will do what they say they will do?
- Do I trust that they are providing a fair price for a quality product and service with consistency throughout relationship?
- Do I trust that they are motivated by my priorities?
- Do I trust that the firm will continue to improve the software over time?
With Documentum and controlled documentation, we see our long-term clients struggle with trust, particularly when:
- D2 is the third attempt at a controlled documentation product (DCM had two starts and stops previously) and requires another software purchase and Documentum Consulting. Clients that have already been through previous upgrades, migrations and revalidation efforts are hesitant to repeat this process again with the same vendor. The is some concern by clients that, like DCM, Documentum might discountinue or redo the software in the future.
- Relationship with life sciences can be strained as many of these long term clients have been through software audits and other aggressive software sales tactics.
To address the trust issue, TSG has tried to build our products and solutions around allowing clients to take small steps along the way to build trust. These include:
- Industry Best Practices/Requirements (call or email for a copy) – to assist in the evaluation process.
- Consumer Application – that runs on “neutral” open source Lucene/Linux to accept approved documents from existing legacy Documentum or new Author/Approver platform as a first step in the migration process.
- Compliance Solution – focused on best practices that supports either Documentum or Alfresco to allow clients to pick and choose a back-end platform, as well as gradually move from Documentum to Alfresco.
- Open Source – we don’t charge for our software products and provide all the source code to our clients, to allowing them to leverage other consulting firms or internal resources. While we promote our products, we want to build trust with our clients that we are not in the business of “software sales” but a consulting company that can bring tools software products to reduce risk and cost.
- Alfresco Alternative – Some of our clients just don’t trust Documentum and are looking for complete alternatives. We have found Alfresco’s quality and capabilities, Alfresco’s pricing model (CPU rather than named user) and sales approach to be much more conducive to building trust than Documentum’s named user and more aggressive sales approach . Related Post – Alfresco for Life Sciences – Response to Client Questions
With the sun setting for Webtop/DCM, many Life Sciences Controlled Document processes will be moving to new solutions. Innovative companies are looking at non-Documentum solutions as part of their evaluation process. Following industry best practices, including separating consumers from authors/approvers, can help in the evaluation process. Clients should look for a vendor solution that works for them today, but also evaluate consulting resources for the future product and consulting relationship based on trust.
Richard Medina says
The post says:
“This is where we differ from Rich’s Doculabs approach as we recommend clients start with a list of requirements that represent industry best practices, rather than creating the list from scratch. Most consulting firms that work in Life Sciences compliance should have a list (email us if you want ours), and can help navigate key stakeholders through the list. Stakeholders should be able to prioritize the must have, nice to have and don’t want components quickly.”
I agree with the post that starting with a pre-existing list is far superior than creating one from scratch. I would have written that part of my post differently if I were writing it now. We often find it useful to break functional requirements into general and specialized requirements. Here’s an example of the questions to ask for general requirements
One of the big themes of the post I just cited — and another thing I should have stressed in my pharma DM post — is that it’s often unproductive to ask business users granular functionality questions. They are great follow-ups, but it’s usually far more productive to first infer functional requirements from focusing primarily on business process-level questions. Then help them navigate through the list.