4.5 Document Control

[Vash Stampede]

Hello everyone,
Do I have to include the following on our Document Control:
1. Running Backups?
2. Electronic media, does this include the software that were using e.g. Microsoft Access?
3. We have a database for material control, would that be considered as electronic quality records?
4. We are starting for the on-line system, what could be the possible thing we can do in which how we can control electronic data?
Any feedback would be appreciated.
Thank you very much.
Vash Stampede
[email protected]
How do i document running backups, do i have to include it in our document control procedure? How about the ele

 

[CJacobsen]

The simple answer to all of your concerns is: YES.
1. Backups of electronic data is necessary. You should spell out in a procedure what is backed up, by whom, how often and where/how to properly/safely store the backup data to prevent loss or damage.
2. Electronic media as it pertains to your Quality System and records, documentation, data, etc. but NOT your basic software like Access.
3. Yes. This should be included in your regular backups.
4. If you are going on-line as in an intranet or the like, there are many programs that support the control of documents and media that is communicated and many methodologies for this. How you do this and what you do to accomplish this will be dependant on how your system is set-up and how you actually use the on-line portion in relation to your quality systems.

Hope this helps!

 

[Jim Triller]

If you are implementing a web-based (intranet)system document control can be accomplished by using server side permissions set by the network administrator. Nothing could be easier nor more cost effective. I have implemented this method at many registered companies without any document control findings.

 

[Marc]

Originally posted by Jim Triller:

....document control can be accomplished by using server side permissions set by the network administrator. Nothing could be easier nor more cost effective.

Yup. It's simple and it works. Plus - no special software.