Anybody with experience with Sharepoint portal for electronic document control?

Bifften

Involved In Discussions
#41
Hi Bifften,

I am new to SP and am further hampered by the fact we do not use Office 2007 yet, so we cannot use all of SP's workflow/approval processes fully (certain buttons are nonexistent, 'grayed out', etc).

Your process for check-in/check-out, approval work flow...any chance that is documented, and i could see how you've explained it to your org?

I am hoping 1. to remedy the mess we initiated some time back when we intro'd SP without proper training to the masses... 2. in the not-so-distant future, to get Office 2007 so i can rip & run!

Thank you!
Hi Irish01 -

Sorry I missed these questions earlier.

I have the check in/check out approval work flow documented as part of the broader Change Control Process.

Once a change is agreed there is a form to complete by the Process Owner which is emailed to the Mapping Administrator . The Mapping Administrator "Checks Out and Edits" the relevant file from SharePoint, makes the draft changes then sets off an approval workflow to the Process Owner. They they review the map and literally have an option to "Aprove" or "Reject" from within the alert. If accepted the remainder of the Form is completed by the Mapping Administrator for physical sign off (my boss insists on this) then the file is updated. If rejected, further ammendments would be made then a second approval flow would be started. Once signed off the Mapping Adminsitator changes the permissions on the file to be public as required and the process is live. Its then upto the Process Owner to consider their own announcement of the process change.

I have this process documented as a Process Map hosted with the other processes. I can't host it here unfortunetly as it has the company name all over it.:)

O/t - At our company the Sharepoint server went down for two days this week meaning no access to any current files for those who use it :mad: Thankfully its back up today.
 
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W

Watchwait

#42
May I re-ask a question that may have gotten lost earlier...

Have any of you Sharepoint users actually validated the application as used in your environment? (Validation, in my case will mean to FDA standards).
 
O

Obstacle3

#43
You can do just about anything in Sharepoint IF you take the time to learn how to do it.

I think its a revelation personally
 
M

machrk

#44
:agree:we've been using Sharepoint for our Global Controlled Documents since Nov 2007 - whilst site ones are still on intranet and some department docs on Documentum

can do a lot in Sharepoint and don't need to be a super user IT geek to get by

KerrieAnne :magic:
 
W

Watchwait

#45
KerrieAnne, Are you a medical device manufacturer? If so how did you handle the validation of Sharepoint? Also, how did you handle the Part 11 requirements? Just curious as we would love to make this low-cost document management solution work in our cost-constrained environment. However, as a medical device manufacturer any systems we used as part of our Quality System must be validated.
 
0

001pk

#46
Watchwait, Im new to the idea of MS SP but from reading these posts (specifically the ones talking about loss of service) could your company afford to be without its operating procedures for a couple of days when the server goes down? and can you be bothered maintaining two document control systems (hard copy and intranet hosted?) if the answer is yes read on...

Other than that from what I can gather it is possible to set up the approval process flow to be 21CFRPt11 compliant buy defining a username and password as a requirement of the approval, and from what I can gather (although this is where my lack of experience in sharepoint might show) it will retain an audit trail of changes.

Validation is a whole other ball game but you can take it as far as you like; do a DQ, IQ, OQ, PQ.... have some Design Qualification in the form of reems of paper from Microsoft saying what SP can do. Have the installing engineer sign an Inastallation Qualification stating its installed and working "within the manufacturers/suppliers published guidelines". Write some user requirements (so what you want from the system) then create Operational Qualification and Performance Qualification tests to see if the system meets your requirements.

and hey presto FDA compliance!
 
W

Watchwait

#47
I believe the process you outlined, if executed successfully, could in fact meet FDA part 11 requirements. That having been said, I suspect this would be a significant amount of work - in particular the validation. It's becoming more & more clear to me how supplier's can charge tens and even hundreds of thousands of $$$ for "plug-and-play" systems. When we did our last price analysis, a significant amount of the up-front cost was for just that - validation. But packaged in a way that one just needed to execute an established, tested script with very little need for modification. Let's face it - most of us medical device manufacturers have (nearly) *exactly* the same document control needs - whether we make tongue depressors or heart valves.

So I see a business opportunity for MS Sharepoint: develop a "canned" validation package for employing your product in a medical device environment! Actually, I'm hoping that one of our inventive list members will realize the value in using this product once the validation hurdles are completed and then "share" this generic validation protocol with his/her fellow colleagues:rolleyes:
 
A

AndrewMcC

#48
Greetings all, I've been reading this topic with great interest as I am currently working on taking our Business Management Guide (encompassing 9001, 14001 and AS 4801) over to Sharepoint. I am taking this opportunity to use my inaugural post on a question for those familiar with document control in SP.

An internal discussion I have been having, particularly with our IT consultant is whether you should be using the relevant Procedure as a metadata tag for any of our controlled forms or records. In theory it seems like it would work and bring some benefits but I have a nagging feeling that I'm opening up a can of worms.

Elaborating on that, our current BMG uses a simple and common three tier structure where all forms and records are grouped under their relevant procedure, and all procedures are grouped under their relevant policy. If we were to adopt this structure as metadata for our documents I could see real benefits in getting others in the company thinking about their documents in a process manner.

Does anyone have any relevant experience on this matter?

Thanks in advance!
 
O

Obstacle3

#49
The metadata columns are the the key to sucess IMHO.

I use it to register document status, owners, related processes/procedures/WINs, version details, custodians, applicable departments etc etc.

I can then create individual views of the data for easy navigation - eg for corrective actions - a view of all open corrective actions...calendar views of upcoming audits etc etc.

We produce documentation and I now use sharepoint to run the business in a "pull" basis rather than a "push" one.

Our commitment to our customers is that we will publish the documents at agreed intervals to the sharepoint, we use the metadata to enable them to have customised views of what they need to see. It is their responsbility to manage their own alerts to get emails if they require automatic notification of the changes.

What it means for us is we can spend more time getting quality into the document, rather than running around trying to manage extensive lists of recipients etc etc.

If we didnt have these metadata columns, I couldnt customise their views and they wouldnt have accepted the process changes.

use them, they are amazing.

If you have any specific questions, let me know and ill see if i can help
 
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