Hi all.

On this somber day, I still have quality issues to get through.

We are trying to use electronic documents in the company. I am not successfully thinking of how to document review of electronic controlled documents. This is to meet the requirement of ISO 17025 4.3.2.2b -"Documents are periodically reviewed ... to ensure continuing suitability and compliance..."

If a change is necessary, then the change shows that someone looked at it. But what if you review an electronic document and determine that it's "ok"...? On hard copy, you can write on it.
Thanks

Hi all.

On this somber day, I still have quality issues to get through.

We are trying to use electronic documents in the company. I am not successfully thinking of how to document review of electronic controlled documents. This is to meet the requirement of ISO 17025 4.3.2.2b -"Documents are periodically reviewed ... to ensure continuing suitability and compliance..."

If a change is necessary, then the change shows that someone looked at it. But what if you review an electronic document and determine that it's "ok"...? On hard copy, you can write on it.
ThanksThere are many ways. How about using a log, or a database with the list of documents.

I use a field in our document control database. Each document approver can run a report at any time to see any documents that (s)he is the approver on, and by the period of time he chooses. From that report, they can automatically open the document and review it for continuing suitability, or even initiate changes if needed.


I have a report that I run that shows all documents that have not been reviewed for the past year (two years, three years) whatever I choose for a time frame.