Is a validated LMS ESSENTIAL?

[DAVID_SZABO]

Hello all - we are about to implement SF LMS having implemented a number of other modules.

Whilst only a small portion of our business today is in Life Science, we need to consider whether implementing the validated solution now is the best route for us or not.

The question I have is whether we could implement the non validated LMS and use other processes to stay in compliance with regulations for our Life Science business, now and in the future as it grows.

I ask this because we don't even have an LMS today in our Life Science business, most records are on paper and we are still able to comply with the business regulatory environment without the sophistication of a validated LMS, so hence my question as to why we should use a validated system at all.

Thank-you

David

[BrianNorton]

Hi @DAVID SZABO

Company History:  Zoetis is the former animal health division of Pfizer.  We had  a hosted LMS (SuccessFactors), and when we got Zoetis up and running, we transitioned to the SaaS model, and the Validated system.

We have come to realize that the validation really wasn't what we had experienced with a hosted solution:  IQ / OQ.

We created / performed our own test scripts to prove the performance of the system.

This started in 2014.  This year, and actually next month, Zoetis is transitioning to the "Non Validated" set of servers.  Same exact LMS, same performance, etc.

As such, we'll get the upgrades on a quarterly basis, rather than having to wait for the annual upgrade.  We will expand our validation testing to include regression testing, to ensure historical data integrity remains.

Good luck with your choice and implementation.

brian.norton@zoetis.com

[Alan_Yang]

Hi Brian,

Thank your for your insight as to what Zoetis is doing. What is Zoetis doing in regards to IQ when moving to the non vSaaS offering? Will SAP/SF be providing an IQ to Zoetis on a Quarterly basis.

Cheers

Alan

[BrianNorton]

@AYang

Hi Alan,

So initially, we asked for permission to perform an on site evaluation of the server farm, which was declined.  We have documentation detailing that.

Subsequent to that, we will point to successful performance testing to confirm viability of the server set up and installation.

Additional FYI - Merck Pharmaceuticals is utilizing the non-validated SaaS model.

Brian

[AF21]

@BrianNorton

What was the process for your transition from Validated to Non-Validated? Were there any tips or insights you could share?

We are looking at gathering more information around Non-Validated including what the process is like for transitioning from Validated and how other businesses handled the IQ report requirments with non-validated.

Thanks,

Angela

[BrianNorton]

@AF2

Hi Angela, sorry it took so long to get back to you.

We performed the transition when we updated our contract with SAP, so the cost was rolled into that.

You would get assigned a project manager / project team to guide you through the transition.

We did it in conjunction with getting into BizX, and that was the more cumbersome part, as that was all new to us.

For the LMS, they simply take all the data from one set of servers and place it into another.  And that's it.  You do some comparative testing to make sure the data transfer is 100%.

Also not, you do lose the sandbox.  So now we only have Staging and Production.  That hasn't proved to be as bad as I thought it might, as we were already years established with the system, and the need for a sandbox for testing has dropped to nothing.

If we try anything radically new, we'll do that work in staging now.

Good Luck,

Brian Norton

[#7]

Hi David,

The decision making process should be driven by the business processes/regulations. To my knowledge, FDA's guideline suggests that if a computer system is used for the regulatory purposes then it should be validated, in compliance with wih 21CFRPart11 (at minimum) and other Codes, as applicable. 

Both, Validated/Non-Validated LMS offer same functions if you compare the same versions. However, the advantage of being on the non-validated tier is that the system is upgraded every quarter as oppose to every year for validated LMS. Now, for some it may be laborious and time consuming - executing test scripts and regression testing every quarter but it can offer more features before it hits the validated LMS. The decision would be driven depedning on the business needs,

We here at Eisai Inc. are on the validated LMS (SaaS).

Note - Implemeting Validated LMS doesn't mean that you have automatically compied with the regulatory guidelines, you still have to follow the guideline and internal process to deem you LMS as "Validated".

Hope this helps!

[DAVID_SZABO]

Thank-you Dhruv,

This is helpful guidance.

Regarding your comment:

Note - Implemeting Validated LMS doesn't mean that you have automatically compied with the regulatory guidelines, you still have to follow the guideline and internal process to deem you LMS as "Validated".

Can the opposite also be true, i.e. implementing a non validated system doesn't mean you won't have automatically complied with the regulatory guidelines, if we implement internal processes to cover the validated needs?

Regards

Dave

[#9]

It (opposite) could be true as well to my knowledge provided you document the processes, have trained admin prior to using the system and your QA team is on-board with the approach. 

[#10]

Hi David,

I work for UCB, a biopharma company.

We implemented the validated LMS in 2016, however SuccessFactors only provides IQ proofs.

No OQ testing is done on thei side, nor PQ.

We could not qualify SF as computerized systems supplier, our contract does not include the opportunity to audit them or complete an audit questionnaire.

We receive the new releases on a yearly basis, and with the technology trends this is not the optimal, as people expect new features quickly.

At the end, you could assess the effort needed on validating the non-validated LMS on your side. It should not be higher that the validated LMS (except of Installation Qualification).

Kind regards,

Sara

[#11]

So the only "benefits" of the Validated option in your judgement are?

1. annual release cycle rather than quarterly (possibly a deteriment)
2. installation qualification documentation

Does SAP do any product validation that they make available to life science customers for each release, similar to say Veeva Systems' approach to validation or ServiceNow's CORE for Life Sciences?

I notice in the validator toolkit that the test case scripts they provide for customers to execute are all listed as OQ.  Do they provide any for PQ?

Thank you for any feedback!