Pinnacle 21 Enterprise needed for creating regulatory submission ?

p Priya

on June 6, 2018

Hi,

Do we need P21 Enterprise to create regulatory submission? We are trying to do the following:

1. validate the data.

2. create define.xml

3. validate data against define.xml

4. create analysis result metadata for ADaM.

4. Not sure, if we need to have coding dictionaries loaded in P21 for any validation purposes?

Can we do all of the above tasks using community version or do we need Enterprise version?

Thanks,

priya

Forums: General Discussion

m Max

on June 8, 2018

P21

Enterprise for creating FDA and PMDA submission

Hi Priya,

P21 Enterprise is not necessary to prepare a regulatory submission, but it sure makes the task easier.

Community will help you validate your data (including against define.xml) to comply with FDA and PMDA requirements. It will also help you generate a define.xml from an Excel template that you’ll need to complete by hand. However, Community does not create analysis result metadata (ARM) nor does it help you with creating a Reviewer’s Guide. These and many other productivity tools are only found in Enterprise, which is why many organizations, including FDA and PMDA, prefer Enterprise.

You can request a demo at https://www.pinnacle21.com/ to help you better understand the differences.

Best,
Max