Document Record Numbers

I'm working to transfer all of our paper documents into electronic copies managed in our EQS.
We're currently working with ISO13485 and 21CFR 820 as our frameworks for our QMS. We've also started to incorporate 21 CFR 211

We are also implementing a record numbering system at the same time.

My question is: What's the acceptable way of adding record numbers to existing records?
We've determined that we will add a box that says:

Quality Record #:_____________
Assigned By: ___________
Date:________

I'm wondering if we need to add these by hand and then scan the documents or if we can add in the box on the PDF before we protect the document and file it.

Thank you for your help

 

Sorry for the delayed reply.

I guess my first question would be to ask why you want to add record numbers to existing records? Are you solving a specific problem? What would the date line be for existing records?

On the surface, it sounds like you're making things more complicated than they need to be.

Regardless, since you'll be storing electronic records, don't forget 21 CFR 11. In all cases, data integrity needs to be maintained so as long as you do that and provide the required protection (and audit trail, etc.), the approach you take is up to you.

 

The records have not been assigned a record number. The paper document is filed in a folder and a quality record number has never been assigned. I am trying to address this gap in our QMS. In order to load them into our Electronic QMS I will need to assign each one a record number.

We are Part 11 compliant and have validated our system using according to GAMP 5 guidelines. Thank you for bringing up this point.

Sorry for the late reply and thank you for your help!

 

Hi,

I reference is very useful for filling and tracking a record. Use a simple coding taking into consideration the following:


Type of the document
Departement which produce it
Year
Serial
etc
For example:

QAD-PRO-2019-0001

QAD = Quality departement
PRO= Procedure
2019=year
0001 = serial number

Understanding this, you net to set a table of codes

Types
Departements

etc.

But all depends on what documents you are handling by who. You need to analyise in order to indentify and codify.

Good luck