3 replies to this topic

[Miss Frankie]

What is the FDA requirements on holding documents on line?
We do a lot of our QA 'paperwork' on tablets, through AirTable.  The techs can fill out forms on tablets and I review them on my computer. 
We've had Airtable about 1 1/2 years and we're reaching our limit and they want us to upgrade (pay them a lot of money)

Is there any reason we couldn't convert older records to excel and save them on the computer?  I'm thinking for now, doing 2022 records.  Then at the end of the year, doing a month at a time.  So there is always 11 months on Airtable.
MOST auditors only look at records in the past 3 months.

 

Do you think FDA, SQF, & WSDA would be okay with this?

[kfromNE]

What is the FDA requirements on holding documents on line?
We do a lot of our QA 'paperwork' on tablets, through AirTable.  The techs can fill out forms on tablets and I review them on my computer. 
We've had Airtable about 1 1/2 years and we're reaching our limit and they want us to upgrade (pay them a lot of money)

Is there any reason we couldn't convert older records to excel and save them on the computer?  I'm thinking for now, doing 2022 records.  Then at the end of the year, doing a month at a time.  So there is always 11 months on Airtable.
MOST auditors only look at records in the past 3 months.

 

Do you think FDA, SQF, & WSDA would be okay with this?

 

FDA and SQF are okay with paper or electronic documents. Not sure what WSDA is. While most auditors don't look back that far - 2 years of records is what they can ask for. If there's a problem - many auditors will ask for earlier records/look for a pattern. 

My facility has a mixture of both. Both the FDA and SQF auditors have been okay with this. 

Edited by kfromNE, 18 October 2023 - 07:39 PM.

[Miss Frankie]

FDA and SQF are okay with paper or electronic documents. Not sure what WSDA is. While most auditors don't look back that far - 2 years of records is what they can ask for. If there's a problem - many auditors will ask for earlier records/look for a pattern. 

My facility has a mixture of both. Both the FDA and SQF auditors have been okay with this. 

Thanks.

 

WSDA = WA State Dept. of Ag.

We looked into and it's actually a LOT cheaper than I was expecting, so we'll probably just upgrade.

[G M]

They will officially care less about what format (physical or electronic) they're in, and more about whether or not you can recover and provide them in a timely manner.   If your records are only available electronically, it will raise the question of how you provide access to them -- will you provide a computer for them to review things on, or are you comfortable sending them copies?

 

Individuals might prefer one or the other, but if they're determined they can go fishing no matter which version is available.