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Are there any regulations stating how many people can have write access to documents?


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#1 Lisa Hefner

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Posted 20 April 2021 - 07:20 PM

Hi everyone! I have a question about document control. I've been at my job in Quality for 6yrs now. A fair amount has been spent in the Document Control Administrator position. My prior boss had always stressed that only one person should be allowed access to the electronic doc site so no one could edit SOPs or forms. My current boss feels multiple people can have read/write access to the various areas that are specific to them. We are an API ingredient manufacturer, that carries certificates for cGMP, SF/SF, Kosher and OMRI. Does any one know of specific regulations stating whether it makes a difference whether one person or ten can have read/write access? Thank You All!



#2 CCSQC

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Posted 20 April 2021 - 07:26 PM

All of our senior management has access to the forms on our public drive.   But I'm pretty much the only one that knows HOW to edit docs, so everyone comes to me with any changes that may be needed.  Our GM will, on occasion make a change, but he always lets me know before he does it.
I keep a notebook of original forms, so if someone needs additional copies, they can use that one to make clean copies w/o having to access the public drive.



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#3 TimG

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Posted 20 April 2021 - 07:36 PM

Hello Lisa,

One thing I want to suggest is that you find the USP-API GMP's.

We manufacture a couple USP grade excipient ingredients here in the plant, and the USP-Excipient GMP guidebook (put out by United States Pharmacopeial Convention) is bananas compared to other standards.

Make sure you get it right from the USP Pharma GMP source if possible, I know my excipient portion has documentation and record review guidelines, but I don't want to share that with you because your API rules might be different.



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#4 johnmcip

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Posted 20 April 2021 - 10:04 PM

If the intent is to allow others to view electronic documents then there's many ways around allowing write access. I have my own controlled word documents in OneDrive that others can view but not edit, and I also export all final revisions to pdf and xps for distribution.

 

Now if the intent is to allow others to edit, godspeed. While training on the document control procedure and followup (i.e. training) may be effective depending on who you're working with, nobody but you will maintain your writing style or meticulous formatting techniques. If you share for edit you must must must be careful who has access. Don't share with anyone that can maliciously or accidentally mess up your system. The allergen control policy cannot be revised by the guy dumping the flour into the machine.

I would also recommend a system where all controlled document revisions must be approved by you. You are the keeper of controlled documents. Others can edit, but those edited documents cannot enter distribution until your signature is on it.

 

Regarding code compliance, I don't know what all those schemas say, but I'm sure they saying something to the effect of "document revisions must be restricted to those trained and competent in both the document control system, and policies worked on."



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#5 Lisa Hefner

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Posted 22 April 2021 - 07:14 PM

All of our senior management has access to the forms on our public drive.   But I'm pretty much the only one that knows HOW to edit docs, so everyone comes to me with any changes that may be needed.  Our GM will, on occasion make a change, but he always lets me know before he does it.
I keep a notebook of original forms, so if someone needs additional copies, they can use that one to make clean copies w/o having to access the public drive.

We are required to access forms and docs from our drive, which shows up to all personnel via an internal website. They only have access to PDFs. If they need to make changes, they request the word doc, and then when they return the revision, I turn it into a PDF and upload to the internal website. So are you the only one allowed to make changes in your public drive? Thank You!



#6 Hoosiersmoker

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Posted 23 April 2021 - 06:51 PM

In our company no one WANTS to change documents whether they have access or not! That being said Myself, QM and Senior management have editing permission and all documents made public are PDF versions of the resident documents on the server.






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