Hi All! So, first, I'm an experienced Sharepoint 2003/2007 IT pro and just love the platform. I recently have been engaged with a medical device manufacturer who lives and breathes according to FDA regulations and GMP and Quality Management. The environment presently is a mix of XP computers, traditional shared network drives, and a bit of visual source safe for document storage and control. While I could espouse how valuable Sharepoint could be to help them regarding their general needs of collaboration, team work, knowledge management, business process management, etc., I'm hoping there may be someone who reads this board and may be able to express more specifically how Sharepoint can fit in to this FDA regulated environment. I tried googling to see if there was any success stories of using Sharepoint 2007/2010 in a similar environment such as ISO 9001 or other related medical device manufacturing environment. But I really didn't hit the mark. So i'm posting this message to see if any of you know of any success stories about how Sharepoint 2010 can be an effective platform in an FDA-regulated, QMS manufacturing environment. I know Sharepoint could handle much of what we need to do. BUt i'm hoping that I can either 1) obtain a case study showing how some other leading organization adopted Sharepoint 2007/2010 in this very specific, non-generic environment, and 2) if there are any products or consultants who specialize in fitting Sharepoint into such an environment. In my background, I've used all kinds of general business uses and find the solution to be incredibly powerful. I know to some extent that the off the shelf features would help our team in general. But they are looking for a platform that is very specific to QMS controls, in addition to general collaboration, business process, configuration management, issue tracking, incident management, and document management revolving around this FDA-regulated need. I will lose the recommendation war if I can't show other case studies of how others have put sharepoint to use in this type of environment. If I can find such supporting information, I will be in a position to help my organization adopt the platform and that would be very exciting. Truth be told, this is the first organization i've worked for in about a decade that didn't have Sharepoint. I'm professionally dying without it here in my role, but the organization also is not getting the benefits of Sharepoint either. (you can't use what you don't have). So for me to make a business case for it, I have to provide supporting evidence of it's use. Thanks, and I look forward to the feedback!Bob

I may be able to hook you up someone who uses MOSS with a NJ based pharma in what sounds like similar cirumstances. Email me at paul.galvin@live.com and I'll make an introduction. --Paul Galvin, Computer Generated Solutions (CGS) Microsoft MVP - SharePoint Blogging @ http://www.mstechblogs.com/paul Twitter @ http://www.twitter.com/pagalvin

Hi bob, I'm a Quality Professional working with a number of Small to Midsize companies in New Jersey implementing Quality Management Systems. All have SharePoint and don't use its full capabilities. I'm looking for a simple way to leverage SharePoint to meet the requirements of ISO 9000, GMP and FDA in a more automated manner implementing an effective workflow QMS with SharePoint. While there are generic SharePoint based QMS on the market they are just that generic and often do not fully satisfy a specific business model. Hence an organization often does not fully benefit from the integration of the SharePoint platform across the enterprise for their business. Most of the companies I work with understand the value of SharePoint but don't know how to leverage it further. I find my self implementing paper based systems to get the job done and certified but know it would be better if it was automated with a system their use to like word, excel and e-mail. While I don't have specific case studies I see the power of implementing a enterprise wide QMS using SharePoint but have trouble finding the resources to implement such systems. In small to mid size companies the IT capabilities are often limited and willingness to customize SharePoint is not there. Can you recommend a group or individual I could contact that could support an implementation of SharePoint tools to satisfy QMS requirements?

HI MWCGeo: So far, I have not had success in identifying solutions using Sharepoint 2010 in a QMS environment. I found this link http://www.quality-sharepoint.com/default.aspx I was watching their videos to understand what they do. It's not bad, but i'm not sure of them as an organization. The quality of their video presentations leaves much to be desired as they used Computer Synthesized speakers and make many language and grammar mistakes. Makes me believe that it's a firm who does not have english as a first language or one who doesn't care so much about the quality of their presentations. It's some what anti-septic. I'm an expert at Sharepoint 2007, but not 2010. And i'm not an expert at all in QMS environments. I'm learning, though. I'm honestly stunned that there's no "meat and potatoes" QMS solutions using Sharepoint 2010 out there. I see all kinds of vertical legacy systems, that while awesome for QMS in general, do not provide any additional value relative to other aspects of business management, project management, knowledge management, team collaboration, etc. Sharepoint is such a powerful potential for aiding engineering, manufacturing resources under QMS environments. But it seems there are no rich solutions out there using it. I may end up giving up this pursuit and accept the reality of using traditional Windows-based legacy/vertical applications. I'm having no luck.Bob

I recommend that you contact Paul Fenton. Paul Fenton VP Pharmaceutical Processes and Technology VP Processus et Technologies Pharmaceutiques pfenton@montrium.com (514) 223-9153 x206 361, St-Joseph Ouest Montreal Qc, Canada, H2V 2P1 Fax: (514) 303-3721 www.montrium.com

Hello Bob, We have build Quality systems based on sharepoint for many years and for many customers (all in Europe). We also have an extended public demo site: http://sharepointservices.nl Can we ask you for a favor? We are very interested in optimizing our system on clients/consultants input. Could you spare some time and surf over the demo site and give us your professional comment? Hope to hear from you. Kind regards, Mario van den Eijnde