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Validation of OTS (Off-the-Shelf) Training Software - Necessary?

G

Gert Sorensen

#11
#11
It seems like it is not so much a question of whether there is a requirement in 21CFR for you to comply to this, but more that you have a customer requirement for it. So, you may want to bite the bullet :)

  1. No validation without proper training, you need a "project lead" who has a proven training within this area.
  2. Be happy, that the system is OTS, that way you can get around the task much easier - see GAMP5 for the requirements for OTS software.
  3. Apply the principles in Part11, and if you can't apply all of them then argue your case in the validation papers as to why you don't need all of it. FDA should accept the "least burdensome approach" and it may be overly burdensome to apply every aspect of part11.
  4. Keep the system under change control to prevent revalidation that is not necessary. Change control ensures that you can argue your validation status.
 
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sagai

sagai

Quite Involved in Discussions
#12
#12
:topic:
Have a theoretical question ... and it driven by curiosity only, others initiatives also interests me.

Why do anything in case there is no regulatory requirements governing that?

If I would finance such business I would be very disappointed knowing spending my money only to make sure things.

thanks in advance, br
Sz.
:topic:
 
H

harry

Super Moderator
#13
#13
I've used Excel spreadsheets extensively in my work for costing purpose, often involving hundreds of items and multi-variables. The mathematics is no rocket science but the spreads sheet is big. Minor mistakes in formulas happens often and there were cases where undetected mistakes cost us a substantial sum.

It is good business practice and prudence to check or validate the spread sheet before use irrespective of whether a requirement is there (especially if mistakes can result in financial loss). Here I mean the formulas you entered, the links, etc and not the spread sheet itself. It doesn't really cost you much if you are familiar with what you are doing.
 
C

Calico

#14
#14
I think the only reason to do anything (validate the system) would only be to satisfy the customer requirements as you say, there are no regulatory requirements. I'm not sure it would even be worth the trouble though so we may just have to stick with paper training records for this particular client. Unfortunate really given that the e-learning system has far superior reporting so we would actually benefit the client more using the online system.

Callie
 
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