Discarding Hard Copy of Records?

We are an early stage medical device company and everything is electronic including our QMS and ERP etc.

Although, We may have some hard copies of records that we don't want to store but the plan is to scan and retain the records electronically.

Now, The key point is that to we want to confirm that the scans are an accurate representative of the original hard copy document and we are thinking of having someone stamp "Scanned & Verified By/Date and # of pages" stamp hard copies and then scan it in to PDF.

Will it be ok to discard hard copies after? Or Is there a need to keep hard copies?

 

Seems stamping the hardcopy with an assertion of scan accuracy is putting the cart before the horse but confirming the scans are accurate is the right approach.

Once you do confirm the scan is accurate, you would not need to keep the hardcopy.

That said, you do now bring in 21 CFR Part 11 into play. You'll also want to ensure your system is compliant with that (control of electronic records).

 

Hi,

All depends on regulatory requirements and to contract issues of your firm with other parties
Find out if it is stated in theses requirements if you need to keep the original of hard copies.

Regards,