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!

You may want to browse this thread:

http://elsmar.com/Forums/showthread.php?t=25365

A lot of software is mentioned.

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:

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...

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:

Gert - Which systems have you found that do have this capability?

Gert - Which systems have you found that do have this capability?

If I remember correctly then EtQ and Master Control has it as a standard module.

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.

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.

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?

Depending on how many licenses you get it can be very costly. We have 10 concurrent user licenses for a 300 person plant. You should be able to get away with less than that. We also maintain some licenses that are "read only" licenses which are cheaper. They work well for users that don't need to approve (sign off) documents or tasks. Is your pricing for the FDA version or non-FDA? From my memory, the FDA version was about twice the cost. I'm not sure but I don't see any real benefits related to the FDA version. We get validation scripts for each upgrade, which saves time, but it is a cost. You could create your own validation scripts which validate your areas of use just as easy. You may want to investigate that option.

If I remember correctly then EtQ and Master Control has it as a standard module.

EtQ does have these standard modules.

EtQ runs on top of Lotus Notes. Notes installation and administration are non-trivial tasks. Configuring EtQ is daunting.

We also use Plateau as our Learning Management system although, at the moment, we haven't turned on the ability to link Doc Control and training.

You could also try Kaplan Eduneering. They are based in the US and they have some pretty sophisticated options around training....I think you can even get to the point where if an operator logs onto a workstation their trainign records are scanned and, if they do not have up-to-date training, they cannot access the equipment! (Don't know if that is up and running yet but I've certainly heard it talked about.)

Obviously that level of sophistication doesn't come cheap but it might give you some more ideas to explore.

Good luck

Dear All,

I am a QSM software vendor.

I just wanted to input that there are many software products that fit your initial requirements. However, if budget is a major concern, you should open up your requirements to software solutions that can be deployed on demand.

We deploy a 21 CFR part 11 compliant, controlled document repository coupled with training tracking as a hosted, subscription, solution. It is very economical for small to mid-sized companies. Cost is per site and not based on number of users. You just need high speed internet access. All validations, datacenter, and security maintenance are covered under the subscription.

Best regards,

Has anyone else had experience with the Plateau application? Also, since I don't believe I may have made this clear in my original request, we are a small device manufacturer and cannot afford $25,000+++ software solutions to this problem. EtQ, Master Control, etc all make great product suites but they are an order of magnitude (pricewise) beyond our reach.

For the original poster,

My company offers a suite of web-based quality management applications for medical products companies, and the Document Control and Training modules definitely address the requirements you've specified so far. We'd be interested in hearing more about your needs, to determine if our solutions would be a good fit for your organization.

In terms of pricing, our solutions are licensed on an annual basis, rather than a large up-front charge. For an organization of your size (200 users or less), the annual fee for the two modules you'd need would be roughly $5K/year. That price includes all necessary support, validation and upgrades.

If you're interested, you can contact us through the website listed in my profile.

Good luck in your search.