‎02-21-2020 5:20 PM
Just bouncing ideas.
I was made aware that the use of E-Signature PIN is redundant. I sort of agree however it is my understanding that it needs to stay on in order to comply with 21CFR Part 11.
I have seen many Life sciences, Pharma, and Medical device companies utilizing the feature in order to stay complaint with the FDA 21CFR Part 11 guideline, is it safe to say that its a required features and is utilized at your company for regulatory audit purposes?
Has anyone terminated the use of E-signature PIN and still be able to use the system's records for regulatory audits?
Your feedback is greatly appreciated!
-Dhruv
‎02-21-2020 7:32 PM
‎02-21-2020 9:11 PM
We want users to verify learning events. We have explored using an extension to let users verify using their network credentials to address constant problems with people forgetting their PIN. We held off on the extension idea, though. In the interim we made changes to the PIN configuration in an effort to lessen the volume of PIN reset requests.
‎02-24-2020 3:48 PM
Jorge,
What changes to the eSign config did you make to lessen PIN reset requests?
Thanks,
John
‎02-24-2020 4:39 PM
‎02-24-2020 4:47 PM
@PKetnouvong - What documentation if any did you qualify the change? How it ever been questioned by the regulators?
@Obuone - We have not implemented the change, just bouncing ideas to hear from someone that has and how do they dodge regulators.
-Dhruv
‎02-24-2020 4:54 PM
‎02-24-2020 4:58 PM
@Dhruv ok got it !
Just to be clear though, are you thinking of not having electronic signature at all, or rather have e-sig but with network passwords instead of PIN ?
‎09-13-2021 2:30 PM
‎09-13-2021 2:35 PM
‎02-24-2020 1:09 PM
Hi @Dhruv
Can you please confirm where would it be documented that electronic signature would be redundant ?
It is heavily used in our current system but would greatly facilitate the usage of the system if we could turn it off (especially the management of PIN + some people simply don't realize they have to sign).
Thanks.
‎02-28-2020 9:40 PM
Today:
We still require learners to submit an e-signature upon completion for training that is considered GxP. We have an integration with our SSO application which eliminates the need to manage user ID and PIN separately in SuccessFactors.
Future:
For our R&D business unit, we have a business decision that as soon as the new business process management system replacing our document management system has the ability to send notifications of process changes, we will no longer require learners to read and acknowledge SOPs in the LMS. We hope to have this functional in place by end of year or early 2021. The decision to no longer require R&A of SOPs in LMS is endorsed by our Quality & Compliance group.
‎03-02-2020 9:13 AM
@Paul Braswell this is very intresting !
We've been thinking of doing the same for a long time as this would have the extra benefit of removing the need for constantly revising R&A items in the system for very little added value.
Thanks for sharing
‎08-24-2021 12:00 PM
Hi Paul,
And do the employees have to acknowledge that their read/learned the changed procedures with an electronic signature in the new business process management system ? Whether they are stored in the LMS or in another system, doesn't the need for an electronic signature remain valid?
We don't have the LDAP integration and are still using the PIN (with the annoying resets) (cf this post trying to change the current implementation).
If yo do have an LDAP integration, are you then still using the mobile app (as it doesn't support that integration)?
Thanks
-Ronny
‎08-24-2021 12:51 PM
Currently we use PINs because we have SSO and we have to have two unique identifiers.
We did a survey with our employees and they did not like having to use a password. We have put as many applications that we could using SSO. Our Validation group still will require the two unique identifiers, but no one wants to go back to using passwords; at this point in time our group likes having to ease of just clicking on the tile to access the LMS.
Marla
‎09-10-2021 2:57 AM
My question is why do we need to use e-signature to show completion of training? It's not required to show completion of training from a regulatory perspective. My thought is that if you use e-signature, then you have to follow Part 11. However, we use an AICC wrapper that we make the user click to say they understand the material. That should be sufficient enough for compliance purposes.
Does anyone else have any other thoughts?
At my previous company also a life science company, we turned off the signature portion for R&U training as the user had to mark the training complete. Of course this was with a different LMS system, but the concept should still be the same.
‎09-10-2021 7:41 AM
We use e-signature for Face to face training in order to avoid the paper signature. In our process the instructor record the partecipation in the classroom or virtual classroom then the user complete the process with his esignature.
The esignature is also a way to collect a comment on each variation of the learning history, just in case you need to make some changes.
‎09-10-2021 7:51 AM
Hello all, I implemented a few years ago LMS for a US Pharma company, quite rigorous regarding FDA constraints. We had this issue of SOPs imported in the LMS where some employees were opening the documents and closing it a few seconds after to make the course Complete (was spotted while reading the courses stats) probably surely without reading them. We decided then to implement the AICC wrapper (the text you write in the AICC wrapper is important to convince the trainee that his/her responsibility is engaged). There was no need for e-signature (we had SSO).
The only issue with such an approach is that you do not check people's understanding of the SOP. This is why I would recommend implementing beside some knowledge checks with Quizz or Exams.
‎09-10-2021 7:54 AM
We also use e-signature as well, however, this was in part due to the fact that we have shared devices in our locations and we use this as a secondary validation rather than simply clicking on the read & acknowledge button
‎09-10-2021 8:31 AM
Hi rorenny,
Could you elaborate why a secondary validation is needed? I assume the learner has already logged in the LMS with his unique credentials and he has confirmed he has ready the document and understood it. Why does he need proof again it was him that did that course? And what validation are you using: the PIN or the LDAP integration?
Thanks,
-Ronny
‎09-10-2021 2:50 PM
Our reason for embracing e-signatures in short: if you are going to have a single approach, you want that approach to serve all scenarios, including the most-complex.
In our validated LMS environment all training completions (classrooom, Virtual, eLearning, and Document) all require an e-signature (learner re-enters SSO credentials, ID and PSWD), whether the training items are or have an associated final test/quiz or not. One reason we don't rely on just a acknowledgment button is that while some training methods (especially DOCs) may use an AICC wrapper (with an "Agree" acknowledgment button to confirm the learner has read/understod the material), this is not a requirement for setup of all items and training methods. For example, while a DOC (read-and-acknowledge) does have an "Agree" button, typically the vast majority of elearnings do not because elearning courses impose their own completion criteria, whether requiring interaction, % test score, % media playback, and/or % slides viewed. Instead an elearning object sends a completion status to the LMS after the completion criteria has been met, and when the LMS tracks completion for all objects within the item the learner is then prompted to provide their SSO logon credentials to e-verify item completion.
I agree with an earlier post that an Agree button alone is too easy for a learner to click without doing anything more. And when the Agree button approach serves many training methods generically, it is a slippery slope to say that it proves much of anything in some scenarios. It is common today for training to contain multiple smaller content objects, not just a single content object or a single assessment object. Examples include an elearning presentation content object and assesment quiz object, or a DOC object with an assessment quiz object, or even more complex or hybrid approaches that require learners to complete 3-12+ content objects all within a single item. While some of these multi-object items may use the AICC wrapper (with simple Agree button to acknowledge completion of each object), other objects (like elearning) impose completion criteria that shouldn't be skipped with a simple Agree button, and still other objects may earn completion credit credit for simply launching the objects. A single e-signature for the entire item provides a single comprehensive/collective confirmation from the learner that they have successfully completed the entire training or activity.
‎09-12-2021 11:17 PM
‎09-13-2021 2:14 AM
Hi, Ronny,
I have implemented vLMS for several pharma & medical device companies. Based upon my experiences throughout these implementations, the esignature is required, even though the user has been verified by SSO, because the standard states the necessity that the esignature be tied to the specific document/training being completed. Having SSO kick-in upon LMS login does not meet that requirement. Just my two cents 🙂
‎09-13-2021 2:57 PM
‎09-15-2021 10:04 AM
Hi Chad,
Indeed, I'm afraid I'll have to live with the requirement to use e-signatures...
As we have to, I want to make that experience (for the end user) as easy as possible. 80% of our support to users is about PIN resets.
How do you (or other customers that didn't pay for the LDAP integration) manage these as there is no common "I forgot my password" link for the learners?
-Ronny
‎09-15-2021 10:23 AM
Hi all,
we just moved from LDAP to PIN to accomodate Mobile deployment; with the move to PIN we introduced a bot to support PIN reset process.
Petra
‎09-15-2021 10:34 AM
Hi Petra,
That sounds an interesting solution. Could you share a bit more about the bot?
Thanks,
-Ronny
‎09-10-2021 8:27 AM
Hi Maria,
Using e-signatures for face-to-face training, replacing the attendance sheet, is a scenario I also feel it makes sense!
Does this mean you don't use it for online training? (Of course, if you don't need to comply to FDA part 11, you don't need to)
And are you using the default PIN implementation or are you paying for the LDAP integration from SAP?
Kr,
-Ronny
‎09-10-2021 8:22 AM
Hi Mike,
We are a Healthcare company and indeed need to follow part 11. Nevertheless, I also dare to question the use/usefullness of a second way of validation (we use SSO and have AICC wrappers to confirm document based training read and understood).
I've had this discussion with our Quality department soooooo many times, but still can't get a better answer then "we are required to do so".
If you (or someone else) have good arguments why we could turn it off, I would be extremely grateful.
-Ronny
‎09-10-2021 4:35 PM
My thought on this as you look at the regulations is that personnel needs to Qualified to perform the task. This is done by giving various mediums of training. One aspect of that is R&U training of a SOPs/WIs . In my opinion, individuals can do the completion and the second verification (pin) and still not truly be qualified to perform a task and be causing non-conformances (deviations) everywhere. Individuals should be going back to the SOP/WI or other document while performing the task.
This was the original case that I used to make the initial case of removing a e-signature for R&U training, when I was running the training department at my company.
Really if you want to have assurance that the individual understands the material that is needed this is where quizzes and exams come into practice. Which really gets into the effectiveness of your training program and not whether a user has a second verification that they read a document.
I would like to hear other opinions.
‎09-15-2021 9:57 AM
‎09-10-2021 8:12 AM
Hi Marla,
I understand that entering a PIN is preferred compared to entering another password...
Could you explain why you "have to have two unique identifiers"?
When I read in Olivier's post that his "US Pharma company" doesn't need a second validation because they have SSO and the AICC wrapper, then why do other companies (including mine!) think we do need a second validation mechanism?
-Ronny