FDA Business rules/ Pinnacle Validation rules

s Saikrishna

on June 10, 2017

Hi Team,

I have questions regarding FDA business rules:

1.) Does Pinnacle 21 Community Version 2.2 checks for latest FDA business rules? To be more vivid configurations we choose from the Pinnacle, some has FDA in the (), does it mean FDA business rules are considered as well?

2.) FDA ID present in validator are they obtained from FDA or they created by Pinnacle?

In 2017 release of FDA business rules I see that FDA ID

“FDAB014”- Category for Disposition Event (DSCAT) should be populated. The identical rule is present in Pinnacle validation rules with different FDA ID “FDAC203” -Category for Disposition Event (DSCAT) should be populated. Does Pinnacle needs an update? Please help me understand how these situations are handled. Thanks in advance.

Thanks,

Sai Krishna.

Forums: General Discussion

s Sergiy

on June 12, 2017

Yes, current P21 checks need an update

Hi Sai Krishna,

Yes, current P21 checks need an update. P21 Community v2.2.0 was released in 2016. New FDA business rules were published in March, 2017.

Kind Regards,

Sergiy

s Saikrishna

on June 12, 2017

FDA rule ID's

Hi Sergiy,

Thanks for the reply. So these FDA validator rule ID's are they from FDA or Pinnacle creates them? I didn't find those rule id's nowhere in FDA older releases of validator rules. Please correct me if I am mistaken.

Thanks,

Sai Krishna.

s Sergiy

on June 13, 2017