Managing Inspection Records with a Database and Destroying Paper Records

C

christyK

#1
A supplier I recently audited has inspection records that are completed on the floor. They are then loaded into a database for gathering metrics. Since all the information is loaded into the database, they have been throwing away the sheets. Is this acceptable?
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Inspection database

Good day christyK,

The answer is a maddening "It depends."

Regulators such as the FDA may require original inspection records to be kept in their original form; that means even scanning of handwritten copies may not be allowable.

Some customers (in my case the U.S. Navy submarine community in which I started in QA by doing inspections of mechanical repairs over 20 years ago) also wanted the hand-written inspection documents kept. They might be researched to investigate an incident. While I was onboard ship this did happen.

There may be more examples.

So the question comes down to who you serve and to which specification or requirement they operate. In any case the requirement should be spelled out in the contracting process.

I hope this helps!
 

yodon

Staff member
Super Moderator
#3
Re: Inspection database

Good day christyK,
Regulators such as the FDA may require original inspection records to be kept in their original form; that means even scanning of handwritten copies may not be allowable.
Let me toss in my thoughts about the above from strictly a medical device perspective. I don't think the FDA would disallow scanning of documents and saving (only) electronic copy as long as the copy is an accurate representation of the original. This would fall under 21 CFR Part 11 and all the requirements that entails.

That said, what was originally posted, though, may not align with the 'accurate representation of the original' part. If ONLY the data is transcribed into the database and the original records are tossed, then what Jennifer said is absolutely true.

And again, what Jennifer said about WHO you're serving is correct. The above is just a perspective with my FDA glasses on.
 

somashekar

Staff member
Super Moderator
#4
A supplier I recently audited has inspection records that are completed on the floor. They are then loaded into a database for gathering metrics. Since all the information is loaded into the database, they have been throwing away the sheets. Is this acceptable?
Why not.
Is it acceptable to you ...
What did you check about that database. Do they have rights to edit only to the authorized person, and only he locks it after loading, which can no longer be tinkered with by anyone including the authorized person., or it is just an .xls wherein anyone can freely change data and text....
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Re: Inspection database

Let me toss in my thoughts about the above from strictly a medical device perspective. I don't think the FDA would disallow scanning of documents and saving (only) electronic copy as long as the copy is an accurate representation of the original. This would fall under 21 CFR Part 11 and all the requirements that entails.

That said, what was originally posted, though, may not align with the 'accurate representation of the original' part. If ONLY the data is transcribed into the database and the original records are tossed, then what Jennifer said is absolutely true.

And again, what Jennifer said about WHO you're serving is correct. The above is just a perspective with my FDA glasses on.
Many thanks to yodon for calling me out on this. :thanks:

I remembered (accurately, I thought but maybe not) discussions on this subject and was recollecting them.

But based on your post I did a Google search and found Part 58, Subpart J of CFR Title 21, Volume 1, and it says true electronic copies of originals can be permitted for nonclinical laboratory results. Chapter 1, Subchapter B, Part 111 says the same for records involved with production of dietary supplements.

And so it may seem as though there is no problem with scanning and maintaining as electronic records, one would just need to do one's own research and make sure it is really okay; I can't vouch for other FDA areas besides the two I linked here.
 
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