For as long as I have known the regulatory tools market space, it has been much more fragmented that it’s peer business functions such as Clinical and Safety. If you take the Regulatory Affairs value chain from Strategy / Submission Planning all the way through Archival, many sponsors use different products / platforms / tools for different functions. Typically you would see a mix of Excel/Spreadsheets to established tools for regulatory document & content management as well as publishing, submissions and archival. This is in contrast with Clinical and Regulatory space where you would typically find 2, if not 3 platforms that can cater to a major portion of the value chain. More than Clinical I would say Safety is probably a better in example to highlight this situation where you’d most likely find 2 products ruling the roost in Oracle Argus and Aris Global’s ARISg (LifeSphere Safety).
This situation in Safety platforms space was not achieved overnight but rather over 5 – 7 years through market consolidation. Oracle essentially bought off all the other reputable and competing tools in the market leaving only ARISg to compete with. Off late there has been a similar trend in the regulatory market with some of the niche tool providers like Octagon, ISI etc. being acquired by larger players like PAREXEL, Accenture, and CSC. While this has resulted in consolidation of the tools/platforms under a smaller set of vendors, these tools still need lot of integration to make them work together. There are vendors like Veeva (Veeva Vault RIM) that have taken a different approach to this problem and have reached a point where they can claim more cohesive platform that integrates out-of-the-box, and as is the case with Safety platforms, caters to majority of the functions in Regulatory Affairs value chain. However the jury is still out whether some of these platforms deliver the value they are expected to since the adoption has just begun and long term use is still not proven.
With the advent of Cloud solutions and adoption becoming a reality in Life Sciences R&D, even though it is much slower as opposed to other industries and even departments within Life Sciences for regulatory reasons, platforms on the cloud with coverage across the Regulatory Affairs value chain can get us closer to RPaaS. The reality of budget challenges across many Life Sciences companies is going to force the issue. For Platform vendors like Veeva and Aris Global the key is interest and willingness to invest by their clients. It will not be a win-win proposition unless each party can look forward to cost reduction, productivity improvement, technology currency and regulatory compliance through these platforms.
I was putting together a presentation for a session on “Enterprise Collaboration and Content Management” earlier this week. As part of the exercise I was making a list of point solutions, in each phase of the Life Sciences value chain, that can be developed using SharePoint. This sources for this list are various articles and publications, customer requests, actual applications that I have seen or delivered to customers and last but not the least, from my own brain. I thought of sharing the list here so it could be useful for some of you and might trigger your imagination on leveraging your SharePoint investments.
My intention is neither to say SharePoint will be a sophisticated solution for all the business needs mentioned above nor that this list is exhaustive. I would like to argue that using SharePoint will definitely be an upgrade from age-old manual and/or paper based process which is still the norm in many organizations. For those who are skeptical about SharePoint being compliant with regulatory requirements like 21 CFR Part 11, I want you to know that it can be “Validated”. May be, that is a topic for another blog post in the future.
As always, your comments and feedback are welcome.
I was asked to provide inputs to help in the decision-making process by a customer of ours who were trying to figure out if they should leverage native SharePoint for their Regulatory Document Management or look for a Commercial-Off-The-Shelf (COTS) package built on top of SharePoint. I have given 5 reasons from my list, below:
1. Customization Vs Configuration
SharePoint, implemented as a Document Management System would provide the ability to store and retrieve documents along with other features like version control etc. However, in order to leverage it for regulatory document management a lot of customization is required in terms of workflow, terminology, metadata, reports etc. In contrast a COTS system comes with flexible, predefined workflow and other features required for regulatory document management system of a Life Sciences organization’s requirement.
2. Rapid Implementation
Traditional SharePoint roll-out may take months to implement and configure it for regulatory requirements like 21 CFR Part 11, Electronic/Digital Signatures etc. On top of that, customization of SharePoint is required to adopt it for regulatory document management. A COTS system implementation is typically completed much faster including validation of the system to comply with regulatory requirements such as 21 CFR part 11.
3. Electronic Signatures, Audit Trail and 21 CFR Part 11 compliance:
Most COTS systems are available with e-signatures that are required as part of 21 CFR Part 11 compliance. A regular SharePoint implementation demands additional effort to be spent to configure this feature such that it is applicable to regulatory document management. The COTS systems also provide audit trail feature which is then leveraged in reporting and assists in audit process.
4. Metadata and Terminology
Meaningful metadata is the key to be able to search and retrieve documents easily. Also, the metadata needs to have fields that are domain specific rather than generic. Traditional SharePoint implementation does not define the metadata required to store regulatory documents whereas most COTS Regulated DMS’ come with predefined metadata for regulatory document management and also has provision to configure these based on organizational requirements.
5. Reports and Audit
Most COTS systems provides reporting capability out of the box. However, these reports are not available in standard SharePoint implementation.
While Cost, Vendor Dependency etc. could be reasons why customers might want to use SharePoint out-of-the-box with some configuration, it will never be the same as a purposefully designed and developed commercial system. As always, feedback and comments are welcome.