I attended a fantastic mini conference yesterday (March 12, 2014) planned by Timlin Enterprises  and hosted by Vertex Pharmaceuticals.  The topic was using SharePoint in Biotech/Pharma environments.  

I spent over 20 years as a scientist, 6 of which in a regulated GMP environment.  GXP (Good Manufacturing/Lab/Clinical Practices) are heavily regulated by the FDA.  Processes must be under control and well documented  (FDA audits are not fun).  Consistency is the rule and the documentation involved is incredible.  These environments are encouraged by the FDA to
take a risk-based approach to change.  

The list of talks:

Bob Meier, Takeda: "eForms & Platform Validation"

• The need:  reduce the # of processes performed by email/paper using manual signatures and fax with an e-form solution (InfoPath) and electronic signature.
•  They built a 21 CFR Part 11 Compliant system with workflows, PDF conversion, Digital signatures (FDA required E-sig, they decided to go one step beyond because of the reportability).
• He discussed validating the form in parts (blocks), so that they validated and qualified a "template" rather than each individual form.
• Their culture already  embraced process improvement and they had staffing to support the tool.
• The benefits to their solution were transparency and increase in productivity.
• They used SharePoint, Nintex, InfoPath, AdLib and CoSign.

Alexey Abramkin, Infinity: "Azure and Infrastructure as a Service (IaaS) for SharePoint 2013"
 This talk centered around using Office 365 vs on-prem vs hybrid.  One of the biggest issues he encountered using a Hybrid solution was that single sign on is difficult to set up

Adila Crimi, Vertex: "Lessons Learned: Collaboration & Project Server Integration"

•  Vertex has a "Center of Excellence" to support SP:  core tactical team that is the customer rep for SP, training, best practices.  They provision sites and provide troubleshooting.
• Separate teams for SP ADmin, Application Development and Information Governance (where to store, retention)
• They chose Organic growth rather than a top down approach.  It's a slower approach but is working for them

 There  was a second part of the talk on setting up MS Project Server:

• Used Project Server 2010 (SP Application).
•  Used Project Widgets, templates and wizards.
• Used a 2-phase approach:
• 1a:  Implement Platfrm (Project Server).
• 1b:  Expand Functionality to get soft links, enhanced reporting, scenario planning.
• Project Widgets was their consulting partner.

Alex Oliver, Novartis: "The Uncertain Future of Forms in SharePoint"
Alex talked about the death of InfoPath 

• EOL is in 2023.
• No new InfoPath beyond SP2013 by Office 365 will continue to support for now.
• MS is still working on a replacement:  MS Access, FoSS and FoSC.
• 3rd party options:  K2 and Nintex.

Patrick Harrington, Cubist: "Adopting a Hybrid SharePoint 2013 Environment"

• SP1 allows connection of My Site to the cloud.

My key take-aways were

1. Office 365, with its lack of backup and continuous updates, is just not suitable for regulated environments.  These environments required control.  Any update must be qualified and validated and the current Office 365 model will not fly. A Hybrid model, utilizing Office 365's social and other collaborative functions for non-GMP work and an on-prem or cloud hosted SP2013 appears to be (in my opinion) a suitable approach.  
• How much is this relevant to HIPA or Sarbanes-Oxley regulations?
2. A couple of the  SharePoint folks I spoke to did not have knowledge of our local SP meetings (BASPUG) and of SharePoint Saturday in Boston (April 12).  One question I got multiple times was "will they only talk about SP2013?  I'm on 2010 (or even 2007)."  
3. The Center of Excellence that Vertex set up was impressive to all in the crowd.  Smart thinking  Too many companies think they can hire one person to do all in SharePoint.  The product is too big and the skills differ between the product itself and helping end users get the most form your investment.  

I'm off to the Granite State SPUG.  Feeling like a SharePoint junky...