In a meeting with my colleague recently we were discussing about some of the challenges faced by customers who bring in certain tools that are easy to use and are adopted multiple groups in the organization in a frenzy and before you know it there is no method to that madness.
Yes, I am talking about SharePoint.
It was developed primary as a tool to make it easy on IT teams to be able to put together websites (Intranet / Extranet / Internet) quickly as well as implement collaboration better with necessary plumbing pre-built. However, the ease of use drove the adoption. The subsequent releases added features like Document & Records Management, Social Media, Insights and even capability to integrate business data from other existing enterprise applications. The problem with such growth is that people use these tools in ways that they were not originally designed for. Once the product teams realize these new ways of using it, they will tweak the design or redesign the tool to fulfill such requirements. This cycle goes on and leads to the evolution of the product.
Any way, coming back to the challenges of adoption without a strategy and governance leads to chaos. As one of my good friends, a SharePoint Architect, puts it “SharePoint is like a Virus !!!” and it needs to be stopped. While we can argue if comparing it with virus is the right way to describe it, his intention is to say that the adoption rate in organizations is phenomenal. If not controlled, this will spin out of control and in no time will lead to people blaming SharePoint for all the problems. To be honest, this is the case pretty much across the board wherever it is adopted without proper strategy and governance.
To derive the maximum benefit out of the SharePoint implementation, one needs:
- A Good Strategy before you bring in SharePoint to ensure it serves the business purpose
- A proper Information Architecture to implement and configure it the right way,
- A good Application Life Cycle Management Process to ensure the applications are created and managed the right way and more importantly retired, once their purpose is served
- A good process to increase the adoption within the organization
- A good training process to ensure that the IT and End User community is trained to use the tool is used the way it ought to be used and
- Last but not least, a good Governance Process to keep it all in check
While the above points would be true for new adoptions, the same goes to organizations struggling with some of the problems as a result of unplanned adoption. They should take a step back and view at the problems they are facing. More often than not they are because they have not followed one or more things from the list above. While it could take a huge effort to clean up the mess that is already created, it is never too late to start adopting some best practices that would steer them in the right direction over a period of time.
A good resource to start with is provided by Microsoft as part of their Tech Net Resource Center. Good Luck with your efforts and do let me know if I can help in any way.
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.
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.