Maintenance of Controlled Terminology files by Pinnacle21

Hi Jon, Pinnacle 21 CT…

Hi Jon, 

Pinnacle 21 CT files are not expected to have any changes over time. That's why we do not have change log documentation for them.

The cases you refer to are due to a bug we had during some transitional period. Being very confident and optimistic, our engineering team still does not expect such bugs in the future and decided that there is no need to have a change log for CT files.

New Community 3.0 introduces auto-updates for CDISC CT as well as patches for bug fix. Release notes for patches will cover changes in existing CT files.

Kind Regards, 

Sergiy   

Controlled Terminology Auto Updates

Hi Sergiy,

With this new CT auto-update feature, when should we expect the newest CT version to be added to Pinnacle 21 Community?  I ask because the most recent version of SEND Terminology (2019-03-29) is not available currently in Community V3.0.  Will there usually be a delay when rolling out the new CDISC CT versions?

Thanks,

Adam

Max

on May 10, 2019

P21

Re: Controlled Terminology Auto Updates

Hi Adam,

Looks like with all the effort to get Community 3.0 released, we forgot to deploy the latest CT to the web service. Thanks for reporting it to us.

We just pushed out the latest terminology via auto-update, If you have Pinnacle ID it will just show up in the drop-down.

Our plan is to have the latest terminologies available via auto-update within 5 days of release by CDISC.

Thanks again,
Max

Follow-up -- expectations for validation of Pinnacle21

Sergiy,

While I appreciate that you don’t expect such issues to occur in the future, my concern is that changes did occur without notification. 

I find it perplexing that the engineer team felt no need to have a change log for the CT files.  This does not adhere to industry expectations regarding change control in a regulated industry.  Your company provided no mechanism to notify the users of your software about the replacement of the five files.  As I suggested, you should have modified the CT Download website adding “(updated on dd-mmm-yyyy)” next to each of the five files to alert people that the content had been changed.

In regards to Community 3.0 introducing auto-updates for CT files, our SOPs, in addition to regulations and industry standards, do not allow for applications to automatically patch themselves.  Such capabilities do not show control of the system, and therefore do not keep the system in a validated, controlled state.  In addition, systems that automatically patch themselves do no provide consistent results limiting the user’s ability to discern the accuracy and reliability of the results.

We have already blocked Community from contacting your update site to keep it in compliance with our SOPs, regulations, and industry standards.  We expect that you will continue to distribute CT Files via the CT Download website even after Community 3.0 is available.  Please advise us if this is not the case.

Jon

Still looking for follow up response

Still looking for follow up response.

Sergiy

on June 6, 2019

P21

How is P21 Community Updated?

Hi Jon, 

Please see https://www.pinnacle21.com/projects/validator/how-is-p21c-updated

Kind Regards, 

Sergiy

Will updated CT files continued to be posted now after Pinn 3.0

Sergiy,

You haven't addressed the availability of Downloads of CT updates in the future.  As I previously stated, our SOPs do no allow for auto-updating of any parts of a validated application.  We have blocked Pinnacle Community from accessing your update site to keep in compliance with our SOPs.  As such we will need to continue to download updated CT files from your website and install them via a change control to the application.

Please respond to this!!!

Thanks!
Jon

Sergiy

on July 2, 2019

P21

Pinnacle 21 Community is a free desktop application

Hi Rob, 

Since Pinnacle 21 Community is a free desktop application, the goal of auto-updates is to maximize efficiency of support for thousands of our users.  

At Pinnacle 21, it’s our mission to help companies of all sizes prepare for efficient and trouble-free submissions. This mission is what drives us to continuously improve and support our open source solution, Pinnacle 21 Community. Every mission has challenges – we have learned over the years that providing free software, free service, and frequent updates is a big ask for a small team. Historically, this challenge has been complicated even further by simultaneously supporting different version of Community because when multiple versions of a product are supported, we spend more time on support and less time fixing actual issues. We also see some companies using older versions of Community that are no longer compatible with FDA and PMDA. To ensure your get issues fixed quickly and that you stay compatible, we introduced auto-updates in 3.0. With this release, auto-updates will provide you the latest controlled terminologies, dictionaries, validation engines, and application updates.

https://www.pinnacle21.com/projects/validator/how-is-p21c-updated

I understand that your company, being a large consulting firm, may have SOPs that conflict with our auto-update process. If your SOPs cannot be adopted, I suggest you consider our Enterprise edition instead. Its update and support model is customizable to the process and needs of each customer.  

Kind Regards, 
Sergiy

CDISC terminology not auto updating

Why isn't CDISC terminology auto updating in P21 v 3.0?