Part-11 Compliant Document Control & Integrated Training Software

W

Watchwait

#1
We are looking to locate a Part-11 compliant document control software with an integrated training function. That is to say, once a document is (elecronically) approved and released, it would be electronically circulated to all required trainees. Once received, the trainee would have to (electronically) acknowledge receipt thus closing the loop from a tracking standpoint (of course the assumption is that the document was read and understood, but that's a seperate issue). The software would also (upon request) enter reports of training "deficiencies" (released documents where training had not yet been complete).

Right now we do all this manually & it is a huge pain - and we're only tracking ~50 quality system documents. I checked with ArenaSolutions (a fairly significant solutions provider) and they do not have this training function integrated.

Given that it's 2008, I assume we're well behind the curve on this and that no one else is still doing this (training) manually! I know there are a fair number of config control/document control solutions available but in this day & age incorporating the integrated trraining function would seem to be almost standard.

In this regard I'd appreciate any comments/suggestions on specific software solutions that your organization has found to be successful.

Thanks!
 
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W

Watchwait

#3
Thnkas Gert! I had actually checked out that thread and I'm following up on several leads mentioned. Since I noticed you were one of the original posters to the thread, does your Doc Control software automatically route revisions for training? If so does it record the training into reports that can be accessed as needed?:thanx:
 
B

B Krause

#4
We are using a system called CAP (Competency: Assessment & Performance) by Soft Design. This is not a document control system per se' but it is a part 11 compliant system for identifying and tracking training requirements via unique sylabi created for each job function.

I also understand that an add-on module is available for developing tests to evaluate the effectiveness of the training.

I hope this helps...
 
G

Gert Sorensen

#5
Thnkas Gert! I had actually checked out that thread and I'm following up on several leads mentioned. Since I noticed you were one of the original posters to the thread, does your Doc Control software automatically route revisions for training? If so does it record the training into reports that can be accessed as needed?:thanx:
Our current system does not have a training module. However, some of the systems that I have been looking at do have one, and when we change this is going to be one of the things that I personally will emphasize.
:bigwave:
 
J

Jun Bautista

#8
We use a software called "Plateau" which does the integration that you are referring to. Our Part 11 compliant documents are archived in "Livelink" that automatically links to Plateau which is a software that tracks and maintains training SOPs and requirements. I can probaly explain this to you better if you call me.
 

rmf180

Involved In Discussions
#9
We utilize Master Control and have recently started using the Training module. The training module is an add-on that can be bundled with your initial contract. The system also has modules for PLM, CAPA, ECO, etc...

Training in Master Control works just like you described. Any document that is identified for retraining will automatically generate training tasks (workflow driven) for all assigned personnel. We utilize an electronic forms process to document if training is required or not. If not, the doc control clerk changes the "route" so that the training task does not initiate. The default setting is launch training.

I'm not sure what else is available. We have used Master Control since 2003.
 
W

Watchwait

#10
Thanks very much for this feedback! MasterControl looks like it can do the job for us. However, the costs being quoted to me were in the $50k-$100k range for a small (80 person) company. Does that range sound close?
 
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