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.
We have come a long way in the last three decades, in terms of computer programs, from Punched Cards to Instruction Sets for Assembly Language Programming (ALP) to Command Line Installations to point-and-click installations. All these methods of programming a computer to automate business processes required step-by-step instructions to install and run the programs for end users to leverage.
I still remember the days when I punched a bunch of Red, Yellow and Green LEDs into a PCB and hooked it up to my 8086 programming kit to simulate the traffic lights. I am glad my program, before I fixed it, was not used for traffic light control systems because it would have been a global disaster :-). Jokes apart, my point is that the instructions that come with software are equally important and will lead to better customer satisfaction, leave alone save the IT teams loads of frustration.
The reason I brought this up is, it is one thing to understand the instructions provided in the installation manuals but it is totally a different beast when you are tackling the Installation Qualification (IQ) requirements with in the Life Sciences space. This process requires every step of the process being recorded, QA Reviewed and signed off. This is all part of the larger Validation & Verification process that is mandated for all IT systems used in the industry (for regulated processes) to ensure regulatory compliance and for a good reason.
While the installation guides provide detailed instructions for the installation of the commercial off the shelf applications, the IT teams will have to go through the process of IQ documents for the same software again. This is not only a tedious process but also requires lot of review cycles to ensure right amount of detail and coverage. I think there is lot of duplication in terms of effort that the COTS vendors as well as the IT teams in life sciences organizations spend to document these steps. My argument is that the vendors of Life Sciences COTS systems should instead provide IQ document in place of the installation guide.
I understand the fact that each customer could have different formats for IQ and also different ways of capturing the steps. However, if a tool vendor provides the IQ document, instead of an installation guide, at least the customers that would be able to adapt the IQ ‘as-is’ will benefit. This will lead to reduction in amount of effort spent, lower costs and faster implementation cycles.
So, I would like to make an appeal to all the Life Sciences COTS vendors out there….”Think About IT“.
Feedback and comments are welcome.