So what is the big deal about Regulated Document Management?

There has been so much discussion about this topic lately that I feel compelled to write about it.  We have so many customers asking: can SharePoint be validated?  The answer is a resounding YES!  My colleague Les Jordan has written about this extensively in his Blog.  We even have a Guidance on Configuring SharePoint for Part 11 Compliance and there is also a very useful recorded Webcast that our partner NextDocs has made available recently: http://www.nextdocs.com/en-us/Pages/Validation-Strategies-for-SharePoint-Solutions.aspx.  There is so much FUD spread by our competitors about SharePoint, which we need to address again and again.  Obviously, it is in their best interest to maintain the status quo, and for their customers to keep on paying for their gold-plated expensive and complex legacy systems.  There is a whole generation of Informatics people whose career was built on these systems, and reason and common sense has often given way to ‘religious debates’ about repositories.  I have spoken at the DIA EDM Conference for the last two years about the topic, and to some people I may sound like a heretic when I say ‘It is not about the repository!’.  And then I usually add ‘It is more about the Metadata’ (see my other Blog postings about this).  The fact of the matter is that legacy document management systems were initially designed to overcome the limitations of file systems, i.e. the lack of version control, metadata, object-level permissions, audit trails etc.  And then when the FDA’s guidance on 21 CFR Part 11 was published in March 2000, companies paid through the nose to upgrade their document management systems to be 21 CFR Part 11 compliant.  This was a really big deal to them, and cost millions.  Of course it was a big deal, because these systems store all the critical content that a pharmaceutical company has to send to the FDA to get their drugs approved.  This is their lifeline, and companies were willing to pay any amount to be compliant, and not to delay the approval of their drug by even a single day (a single day of delay could mean millions in lost revenue).

But despite all this, they are still using these ‘glorified file systems’.  I do not mean to trivialize the importance of document management, because file systems are clearly not suitable for compliant applications.  However, there is no reason why these legacy document management systems should be so complex and expensive!  When I came to work for Microsoft, I was really excited by the power of SharePoint as a platform.  I saw huge potential to build then next-generation document management systems on the SharePoint platform.  So one of the first things I set out was to write a White Paper called Enterprise Content Management in Regulated Industries, so we could establish our vision.  Here is also another excellent White Paper on Compliance: Compliance Features in the 2007 Microsoft Office System.  The next step was to realize our vision, and to recruit partners to develop SharePoint-based solutions for 21 CFR Part 11 applications.  When we first demoed our solutions back in 2007, even the analysts started taking notice.  Today, we have several large pharmaceutical companies who have already validated SharePoint on their own, or via some of our systems integrator (SI) partners.  See the recently published Case Study about Roche Diagnostics, where they replaced Documentum with SharePoint for all validated IT documentation.  We recently released another Case Study on Affymetrix, who also replaced Documentum with SharePoint.

I also need to address some misconceptions around validation.  First of all, there is no such thing as FDA validated software.  Any software vendor who states is showing their ignorance.  Validation is the responsibility of the customer.  And it is not the software alone that needs to be validated, but the whole environment, which includes hardware, software and even internal processes.  And then there is the question of why one would want to validate SharePoint itself.  For sure, SharePoint needs to be a ‘validatable’ platform, which it is.  But instead of validating all SharePoint, only the application that runs on SharePoint for a particular GxP application needs to be validated.  This means that the application needs to be built, and then validated.

However, I am strongly opposed to building one-off applications for several reasons.  I have found that in over 95% of the cases, pharmaceutical customers need the same kind of capabilities.  Therefore, why not use off-the-shelf applications, and configure them?  I always recommend considering this approach first!  This way, the costs of building the application, and developing the validation test scripts and protocols are amortized over many customers, and the overall costs are far less.  Unfortunately, many companies who are still used to the old ways of doing things still don’t seem to understand this.  There are several partners who have built off-the-shelf or ready-to-deploy SharePoint-based solutions for 21 CFR Part 11 compliance: NextDocs, OrniPoint, Qumas, FirstPoint by CSC Life Sciences, Montrium, Court Square, GxPi, and several additional solutions along nicely.

Among the off-the-shelf solutions, NextDocs has been gaining a tremendous amount of market momentum, and they have done a superb job with their applications.  I love to see people’s faces when they get a demo of the solution and they compare it with the old legacy systems they are struggling with, and get really excited.  It really brings out the best of SharePoint.  I also love their slogan ‘Compliance without the complexity’ – it is spot on!  They have just posted a series of recorded Webcasts on their Site – they are great!  I know that we also have to be realistic, because these legacy highly customized systems are so deeply embedded within corporations that they cannot be just ripped out and replaced overnight.  That is in nobody’s interest, and way too disruptive.  However, there are many GxP applications where people have a real need for such solutions, and are still doing everything on paper because they just cannot afford these gold-plated ancient solutions.  Validation alone for these legacy solutions could take 6-9 months and up to 7 figures, whereas we have several cases where one of the above off-the-shelf solutions had been installed and validated within a manner of weeks!  AS CIO’s are under increasing pressure to cut costs, there are no more sacred cows, and they will be looking at every single legacy system they can replace, and save millions in the process.  I know of several major pharmaceutical companies where they have spent in excess of $50 million just upgrading and consolidating their legacy ECM systems.  A brand new implementation of a SharePoint-based ECM system (including migration, or integration) would be a small fraction of this.  And now they have just locked themselves in for the next 5-10 years, and are at the mercy of armies of consultants to keep these monolithic behemoths running, and integrated with their other enterprise systems.  Someone with decision-making powers needs to stand up, and say ‘stop this insanity’!

And now I need to address the issue of scalability.  The legacy vendors are spreading FUD that SharePoint is not enterprise-ready and scalable.  As an example, see here for some information about Pfizer’s implementation of SharePointGlaxoSmithKline has announced that they are rolling out SharePoint Online to over 100,000 users.  BMS runs on SharePoint, and so is the Univadis Site that Merck has launched.  The U.S. Air Force operates what is probably largest Extranet in the world with over 750,000 users – built on SharePoint.

I have also posted some documents here about SharePoint scalability.  The results are amazing: scalability up to 2 million users!  And here are the latest results of the SharePoint Server 2010 performance and capacity test results and recommendations.  I doubt if any legacy ECM system can produce similar results, when all the parameters are compared.  The main point here is that like with any other system, it has to be architected right, and deployed in the right manner!

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