Boilerplate language for regulatory documents

support
Boilerplate language for regulatory documents brittany  2021-09-22 16:53:26
 

Hello

I was wondering if you provide and/or prefer standard language for use of AutoQC in describing quality control protocols in regulatory documents?

Thank you
Brittany

 
 
vsharma responded:  2021-09-23 07:21:10

Hi Brittany,

Could you please give us more details about what you need so that someone with experience in regulated environments can better answer your question?

Thanks for using the support board.

-Vagisha

 
brittany responded:  2021-09-23 09:11:27

Hello

We plan to use AutoQC to track sample acquisition of a clinical trial. We are writing an IRB and want to reassure that the data will be quality controlled and monitored using AutoQC. No patient sample alone will be analyzed with AutoQC but pooled samples and QC standards will. I was just wondering if you has any standard language you provide or prefer the use of when writing regulatory documents.

Thank you for your help with this,
Brittany

 
jeckels responded:  2021-09-29 14:28:44

Hi Brittany,

Thanks for the additional context. I haven't seen any copy/paste-ready boilerplate to help support AutoQC's usage like this, but we are looking to improve what we offer in regulated environments.

If you haven't already discovered it, the publication describing AutoQC is a useful reference. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5406750/

And this support board posting discusses some of the audit logging and progress towards full CFR Part 11 compliance (which I know is not your requirement, but may have overlap). https://skyline.ms/announcements/home/support/thread.view?rowId=46032

Please consider sharing anything that you put together as it may help others, and help us fill in gaps.

Thanks,
Josh