Training Software with Internal Auditing Module

Hi All,

I'm looking for recommendations on some software. I know there are a ton of threads out there for document control (we are using Sharepoint at this point which is working OK). What I'm looking for is something inexpensive (of course) that has different modules. Ideally one module would be for tracking of employee training but I also would like a module to track internal audit corrective actions etc.

Does anyone have anything that is working well for them? We have approx 250 users which could go up to 300 in the future.

We are following 21 CFR Part 820 regs at this point. We are a call center that takes calls for pharmacies from pharmacists and patients.

Thanks,
Callie

Are you looking for something web based or a desktop application?
What server environment are you looking for (windows/linux/etc)?
What database environment are you looking for (SQL Server/MySQL/etc)?
What is considered inexpensive to you?

I'm thinking web based would be easier for the users but I'm open to suggestions. We are currently running Windows XP on mainly Dell Computers. Not sure about the database environment, maybe SQL? I woudl have to check with IT.

Our IT department said they could build something (just training, not the internal audit module) for approx $5000.00 not including the 80+ hours of man time.

Callie

Would a "hosted" option be acceptable where the application and data are hosted by the software provider?

Our IT department said they could build something (just training, not the internal audit module) for approx $5000.00 not including the 80+ hours of man time.

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Is that $5000 just for hardware?

I also would like a module to track internal audit corrective actions etc.

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Do you desire a corrective action module to use for all quality system corrective actions and not just corrective actions for internal audits?
What does etc entail?

You mentioned document management, in what form do the training/audit/corrective action records reside; is each record a file? Or, are you looking for records to reside in a database?

Calico said:

(we are using Sharepoint at this point which is working OK).

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Just out of curiousity, you mention sharepoint is working "OK", what are the downfalls and what is prompting you to find another solution?

Calico said:

Hi All,

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Calico said:

I'm looking for recommendations on some software. I know there are a ton of threads out there for document control (we are using Sharepoint at this point which is working OK). What I'm looking for is something inexpensive (of course) that has different modules. Ideally one module would be for tracking of employee training but I also would like a module to track internal audit corrective actions etc.

Does anyone have anything that is working well for them? We have approx 250 users which could go up to 300 in the future.

We are following 21 CFR Part 820 regs at this point. We are a call center that takes calls for pharmacies from pharmacists and patients.

Thanks,
Callie

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You may want to check out Cebos. They sell a complete integrated system but can sell CA and training modules separately. It would be less than what your IT department quoted you.

Disclaimer - I have done some consulting work for them in the past, so this can not be considered unbiased, please look and decide for yourself.

OTS Training Software - Validation Required?

Hi All,

We use an off the shelf training module called MC Strategies. Several of our clients (pharmaceutical companies) have asked for evidence that this training module was validated.

My organization is part of a hospital and the training module that we use actually was purchased by the hospital. Nobody actually did any validation on this system.

We only use it to track the training of Standard Operating Procedures and Work Instructions.

My question is (from an FDA perspective which are the regs that we follow 21CFR Part 820 even though we are ONLY a call center) what would validation requirements really be for a system that is only used for sending out training to employees, tracking the training and providing reports?

Would it be sufficient to simply come up with some test script questions around logging on to the system, taking the training etc..?

Thanks so much for your help!
Callie