Electronic records in lieu of paper records

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
1

Hello,

We are implementing an Electronic Documentation System in my plant (IDEA forCon), that aplies part 11, and we have designed a flow chart with the standar tools of the system to create, modify, mantain and sign the SOPs of the plant. All the existing SOPs (in paper format) will be scanned and charged in the system through an accurate process that belogs to the validation cycle.
The established statement by the corporation (based on famous Guideline 2003) is that these documents cannot be considered as electronic records and only a new version edited from that existing created into the system, it can be, and, the use for this documents cannot be for official purposes (controled copies) but information use.

In my opinion that approach, limit, unhelpfully, the use of the system and does not confer additional security to electronic records.

Could you give me some feedback please?
Sincerely,

Carina Marcos.

2

I think this is correct, these are not electronic records but records that were paper based stored on durable media. No update or edit can be made to these documents (I assume they are in PDF format)

It’s hard to comment further when the details are not clear.

For example if an update has to happen to one of these documents how would this occur. Would you make the change to the word copy , PDF it and then upload to the system?

More details required please…

3

we are using tray drier for intermediade drying.Now we have palnned to swith over the tray drier to vacuum tray drier at same parameters. Pl. suggest what is impact as per regulatory guidance

regards

4

karina-

Once these documents are scanned and become part of your electronic data management system (EDMS) they are considered electronic records and will have to comply with 21 CFR regulations.