In recent years the Life Sciences industry has seen many product recalls and withdrawals from market due to safety concerns from patients and the resultant actions by regulators. Pharmacovigilance has become a more proactive process as opposed to a more reactionary process in the past.
Electronic data collection and submission of Adverse Events (AEs) in recent years has enabled organizations to collect huge data sets of safety information. Some pharmaceutical organizations have invested heavily on building or procuring IT systems that can analyze these datasets and produce safety observations that have the potential to become signals. This method of applying mathematical / scientific statistical algorithms to identify potential signals is termed as ‘Quantitative Signal Detection’. Another way of identifying safety observations is the manual process of reviewing all cases being reported, by a medical professional, to identify potential signals. This process is termed as ‘Qualitative Signal Detection’. Many small to medium organizations employ this method of detecting potential signals. More than the size, it is the volume of cases that need to be analyzed that would be a key criterion for organizations leaning one way or the other. Some organizations may also employ a hybrid model i.e. quantitative analysis followed by qualitative analysis.
Microsoft SharePoint is a very popular collaboration and content management platform adopted by many organizations across the globe. Life Sciences organizations are no exception to this trend. In recent years SharePoint has seen rapid growth in even areas that require more cautious adoption of new technology due to the impending regulatory requirements (e.g. 21 CFR Part 11 compliance). However, due to the efforts from Microsoft as well as other IT and Life Sciences organizations SharePoint is being adopted in areas where it requires validation.
Signal Management, the process that ensues once the Signals are detected using one of the two methods i.e. Qualitative or Quantitative Signal Detection, is the process where the information related to a safety observation and the corresponding cases that lead to the observation are reviewed by professionals and scientists and decision is made on whether the signal is refuted or verified (other states are also possible). The information is usually captured in forms and passes on from one state to another following a specific workflow with associated service levels for each step in the process. This yields itself as a potential candidate for automation. SharePoint natively supports configuration of forms, management of documents as well as simple workflows. As mentioned above, many organizations have already made investments in SharePoint and hence will be able to save costs by leveraging this tool for Signal Management automation.
Update on 02/15/2012: Please refer to an article by me, on this topic, published by “Drug Safety Directions” here: Signal Management using SharePoint
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.
I have been an ardent fan of Microsoft for a long time. Don’t think for a second that I am writing this because I have switched sides or about to. I will continue my fandom to Microsoft despite some of their blunders during the past decade. They have made life easy for a lot of users and developers alike in the 90s, like me, with their innovative and often ridiculed UI rich operating system, applications and tools. I still happen to think that the tools provided by MS make life easy for the developers to build some of the slickest of applications with minimal effort. I know that is debatable but that is my opinion and I am sticking with it.
One of the biggest mistakes, I think, they committed in the last few years is not cashing in on their early entry into the mobile computing. While there are still a lot of handheld devices used across the world for business purposes, from a consumer stand point they missed the bus. Despite that I have been waiting for a long time to find a decent windows based gadget like the iPad, but in vain. So I eventually took the plunge and bought one iPad 2.0, despite having 2 laptops at home.
The primary reason I bought iPad was for it to be my reading and learning gadget. May be that’s two reasons :-). Basically for news, videos, virtual learning so on and so forth. While I knew that Apple has taken a stand not to run flash on their gadgets, I didn’t realize that it would be that big a deal. Fast forward a few months, now I can’t really view any websites that are done in flash. Not only that but I can’t run through some virtual learning classes that some of our vendors have made available for us to enhance our knowledge. This is becoming more and more of an annoying problem as I originally imagined I could lay down on my bed and go through these videos. Now, 50% of my primary purpose(s) is defeated.
If you think about it for a second, it appears really ridiculous how a vendor like Apple can take such a stand. Even more ridiculous is how they can get away with it. While they may have their reasons for it, the decision is hurting two parties the most. One, people like me who would love to use flash content. Two, Adobe. It not only prevents them from expanding their footprint but also brands their product lousy.
So now, I think iPad sucks, with out flash content. But for that, it is still an amazing gadget. While I would love to use it more often, this one big challenge is limiting me from enjoying it to the fullest. I am not sure if this is gonna ever be solved. So, I guess I have to live with it, just like many other decisions I might have made along the way.