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Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
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E-Signature Compliance Requirements for Training Records


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electronic records, electronic signatures and approvals, fda requirements, records (evidence) and records control, training (general), training records
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  Post Number #1  
Old 27th February 2012, 03:33 PM
dendel

 
 
Total Posts: 5
Please Help! E-Signature Compliance Requirements for Training Records

Hello,
This may be a no-brainer.. but, I'm not sure.
We are planning to purchase company-wide training SW.
This new Vendor-provided training software will require my Companyís system access requirements (id and password) before being allowed to continue access in order for us to train to required documents.
Question... At the completion of a given document training, Which of the two scenarios would be more or less sufficient for complying to e-signature requirements.
1. Training system shows a button after completion. The user only has to click on the button and that is all. The Training software will then record that training per that personís original sign-on. A report can be viewed or printed showing the personís name associated with that training.

2. Training system shows a button after completion. It then requires the same password entry as before (when logging onto the system). Clicking the entry of the password submits the training record. The report can then be viewed or printed.
Do both scenarios satisfy electronic records complaince? Or not quite.
thanks for your help.

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  Post Number #2  
Old 27th February 2012, 04:28 PM
Ninja's Avatar
Ninja

 
 
Total Posts: 484
Re: E-signature compliance for Training record

My ,

Either should be fine if you can display that only authorized trainers can tag a person as trained. The plan is great...but does it work? Can you show it? What safeguards? What testing?

Using many systems like this that I've built myself, I've found it far more convenient to click the button then enter the password. You never know who's account you may be working in at the given time and logging out then back in is a PITA when you have to do it 50 times in a day.

Make the button available to all accounts, and the first action after clicking it is a password entry request. This way a trainer can mark a training record complete even when the trainee is the one logged in.
Thanks to Ninja for your informative Post and/or Attachment!
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  Post Number #3  
Old 29th February 2012, 09:20 AM
c.mitch's Avatar
c.mitch

 
 
Total Posts: 153
Re: E-Signature Compliance Requirements for Training Records

My other two pennies,

I prefer option 2, re-enter password is one method to verify that the user who logged-in is the one who signs the record.
IMHO, both options satisfy electronic record compliance, provided that training records are time-stamped.

By the way, do you really have to adhere to 21CFR part 11, if you print the training records???
Have a look at the narrow interpretation of scope in this guidance:
http://www.fda.gov/regulatoryinforma.../ucm125067.htm

Regards.
  Post Number #4  
Old 29th February 2012, 01:47 PM
dendel

 
 
Total Posts: 5
Re: E-Signature Compliance Requirements for Training Records

thanks, point taken re: printed records. I"ll verify our intended practice...for either paper or electronic records.
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