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A customer recently asked about Velquest SmartShell "for improving audit
trails etc. to comply with CFR part 21"

JMP and VelQuest Partner to Provide Compliance Option for Life Sciences

Anyone know anything about this? Do we still support this? Do we offer any other solution?

Thanks,

Phil

Re: Velquest SmartShell

I have put them in touch with Predictum. I will let you know how they get on.

Thanks again,

Phil

Re: Velquest SmartShell

I am not positive but I think Abbott Labs used this wrapper about 8 or 10 years ago for stability data. They hired us to write a script to work in the environment for stability analysis per their own SOP.

Re: Velquest SmartShell

Many thanks for all your comments. I'll have a chat with the customer and let you know how we get on.

Thanks again,

Phil

Re: Velquest SmartShell

I might add that I always placed in my laboratory notebook and in the server folder I previously mentioned copies of:

1) My analysis output,

2) My data table, and

3) The script to generate the analysis output.

That way, pretty much anyone could exactly reproduce my work.

Re: Velquest SmartShell

The small company I worked for prior to joining JMP dealt with this issue simply using folder permissions on a server. When I was finished working on my JMP files (or any other electronic files, for that matter), I placed them in a special folder on a server. From there, a batch processor moved them to another folder to which only the batch processor and administrators had write access. If I needed to change anything, I had to open the file up and save the changes in a new file, so the original was preserved.

This wasn't a perfect system, and it definitely did not include an audit trail. Either way, it worked for us and never caused any compliance issues. I definitely am interested in hearing about how other companies handle this--either with or without additional software--as this issue comes up occasionally in discussions with my customers, as well.

Re: Velquest SmartShell

JMP Clinical is in the same boat and has the same limitations as JMP except for tracking snapshot changes (data changes) from a reference point or building reviews/workflows that are guided and control. SDD (what Malcolm has mentioned) could help from the data point of view as far as real tracking of data and data changes as far as 21 CFR Part 11 compliance (which is part of the intent of VelQuest SmartShell). Another option is talking to Wayne Levin from Predictum (http://predictum.com/) . He has worked out a solution for tracking of what people do in JMP and guide them with the intent to allow for 21 CFR Part 11 compliance.

Chris Kirchberg

JMP Technical Enablement Engineer

Worldwide Technical Enablement Team

SAS Institute, Inc.

100 SAS Campus Drive | Building T | Cary, NC 27513

Tel: +1-919-531-9927<>

Mobile: +1-303-378-7419<>

E-mail: chris.kirchberg@jmp.com

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Re: Velquest SmartShell

Perhaps SAS Drug Development is more aligned to what they need: SAS® Drug Development | SAS

Malcolm

Re: Velquest SmartShell

Hi Chris,

I thought that was the case.

Would JMP Clinical offer a solution for the customers challenge: "improving audit trails etc. to comply with CFR part 21"?

Thanks,

Phil

Re: Velquest SmartShell

Hi Phil,

My understanding was that this was some wrapper around JMP, but nothing within JMP was modified to accommodate this option. I have not seen it in action so I don’t know the details of how it works or even if it still works (or if VelQuest still exists: http://www.businesswire.com/news/home/20120103005296/en/Accelrys-Acquires-VelQuest-Corporation-35-Million-Cash#.VT5X59F0yHs)

Accelrys is now somebody else and I doubt that Velquest SmartShell is around anymore since I cannot find any other information on the web other than the link you provided (infact, other links point to pages that are 404 page not found!).

Chris Kirchberg

JMP Technical Enablement Engineer

Worldwide Technical Enablement Team

SAS Institute, Inc.

100 SAS Campus Drive | Building T | Cary, NC 27513

Tel: +1-919-531-9927<>

Mobile: +1-303-378-7419<>

E-mail: chris.kirchberg@jmp.com

Unsubscribe<>