General Discussion

Hello P21 Team - Could some one please suggest where is the link to download P21 version 3.1.2?

I could not find it. The only version that available on downloads is P21 version 4.

Please advice.

Thanks,
Deepa

We are trying to find out what is the difference between version version 3.0.2 and version 3.1.4 and what does it each that other does not?  Also, is version 3.1.4 the highest version in 3.x version? Can someone please confirm?

Hi all,

May I know what is the difference between free version and paid version of P21 validator?

Can the free version be used for FDA submission of deliverables? Is there any concerns about the compliance of using the free version?

Thank you!

John

Hi,

It seems like the updated define2-0-0.xsl has this VML button function embedded; and I am wondering how should we incorporate that into define.pdf. We want .pdf to align with .xml as much as possible. Is there any suggestions? I realized that define.pdf is not required for submission, but it is asked by our customer. 

Thx!

Weijie

Hi Team P21,

                         We love using P21 community version and to further use it with recently introduced company level guidelines, I need to provide IQ/OQ for all the softwares we use. Is there a place that I can gather these details similar to let's say SAS: https://support.sas.com/documentation/installcenter/en/ikinstqualtoolug/66614/PDF/default/qualification_tools_guide.pdf

Regards,

P21 early adopter.

Can someone explain the note of TI.TIRL, "Rule that expresses the criterion in computer-executable form", or provide an example for TIRL mapping? Thanks.

We know that v2.2.0 is not supported since 31-Mar-2021 but can we check that this version will remain accessible on the long term?

It appears there is a new version of the software, but there are no release notes or information about what changed; the downloads page still says v3.1.0.  Please advise on the changes for the software.  Thank you.

based on paper {How to Automate Validation with Pinnacle 21 Command Line Interface and SAS®}

like below code, bold line is new added based on paper. 

/*4. Define Template Generator*/
x
java -jar "&jarpath.\&jarfile." ^
--standard=sdtm ^
--standard.version=3.3 ^
--source.sdtm="&sdtmpath." ^
--source.encoding=UTF-8 ^
--meddra.encoding=23.0 ^
--cdisc.ct.sdtm.version=2020-11-06 ^
--output.format=define-excel ^
--output="&reportpath.\sdtm_define_template.xlsx" ^
;

Dear Support,

Pinnacle 3.1.0 stopped working with the error message "Installation qualification check Expiration date check failed". We have an offline environment. With earlier Pinnacle versions (3.0.2), a reinstallation would work. However with 3.1.0, reinstallation does not. Even installing on another machine gave the same error message. Any suggestions would be much appreciated.

Best regards,

Mathias