Document control system for QMS in Google Drive?
- Thread starter asantcom
- Start date
ChrisM
Quite Involved in Discussions
Did this recently but there are cautions:
First you have to make sure that you restrict "write" access appropriately, second where for example a document register is on Google Drive and you may need to keep a copy of all versions, you need a foolproof way to do this since usually, any edit to the "master" document on Google drive instantly updates it and you lose info on the previous version.
Google drive also ignores any password protection in Microsoft Excel documents, maybe the same for Word documents, I never got to test that out.
A good tip if you have an excel spreadsheet you want to edit but has a password lock, and you don't know the password, is to upload/convert it to Google Sheets since as I stated above, Google Docs doesn't recognise Microsoft's basic security measures on documents........
First you have to make sure that you restrict "write" access appropriately, second where for example a document register is on Google Drive and you may need to keep a copy of all versions, you need a foolproof way to do this since usually, any edit to the "master" document on Google drive instantly updates it and you lose info on the previous version.
Google drive also ignores any password protection in Microsoft Excel documents, maybe the same for Word documents, I never got to test that out.
A good tip if you have an excel spreadsheet you want to edit but has a password lock, and you don't know the password, is to upload/convert it to Google Sheets since as I stated above, Google Docs doesn't recognise Microsoft's basic security measures on documents........
Yes, I work for a very small nonprofit. Was tasked for setting up our QMS. I've read ISO 13485 standards, added a few things from MDSAP audit checklist for the EU, now I'm figuring out how to go about implementation. Starting with figuring out the document control system. Ideally, we would use Drive
Thank you so much! Can I ask what your review/approval process was like? Also, how did you go about signatures? Thanks so much
ChrisM
Quite Involved in Discussions
Our approval system consisted of retaining emails where people added their signatures as scanned images to the documents when they approved them, only pdf copies were placed onto the network for people to access - except for blank form templates that needed to be in editable format so people could copy and use them. There was a separate folder for "master" forms that was write-protected except for access by 2 nominated people.
The above may not stand up to FDA requirements for medical devices, but for "general" QA purposes it demonstrated a degree of control that we deemed adequate. Even with pen and ink signatures on paper documents, there is always the possibility of someone forging a signature. The alternative of subscribing to one of the online "secure signature" system providers was deemed too complex and too expensive for our needs.
The above may not stand up to FDA requirements for medical devices, but for "general" QA purposes it demonstrated a degree of control that we deemed adequate. Even with pen and ink signatures on paper documents, there is always the possibility of someone forging a signature. The alternative of subscribing to one of the online "secure signature" system providers was deemed too complex and too expensive for our needs.
Swimming In The Soup
Involved In Discussions
I just migrated our FDA regulated QMS from Excel based to Cognidox eDMS after a recommendation on this forum. It is very nice. I hear everyone about compliance at low cost. I am not trying to sell the service but Cognidox is extremely reasonable and eliminates all the pitfalls of preservation of data, compliant approvals, document routing, workflows. It does a great job at all of that. We are a small company so price was a deciding factor. What I realized pretty quickly was that the elimination of the walk about signatures and constant printing and scanning paid for the service. We are saving so much time with the routing functions. My sales rep is around on this forum. He always likes to talk about the platform. Look for Simon Roberts here. He can explain the benefits better than I can. No high pressure sales either. Hope this contributes to your conversation.
Similar threads
