From Dwayne Wright PMP, PMI-ACP, CSM
Certified FileMaker Developer
A READER ASKS
I had a couple of questions that I was wondering if you might be able to answer.
1. We need to make sure our database is compliant with the FDA regulations (21 CFR part 11). One of the requirements is that we implement an audit trail that tracks every time (date and time) a user accesses the database and every time a user makes a change to a record, creates a record or deletes a record. Is this something that FMP 8.0 can do? If so, is it easy to figure out? Any suggestions?
2. We are putting together a network and want several users to be able to access and use the database at one time. My understanding is that we can purchase a network upgrade to FMP 8.0 that will enable this. Am I correct? If so, is there anything that we should be concerned with in terms of hardware requirements, etc.?
I’m not sure that I have THE ANSWER but here are some answers that might help along the way.
I’d have to research the FDA regulations more to know exactly what those requirements are and that is something I’d have to charge a consulting fee for. If you want to have me do that, please let me know. Here is some information that might help you before we go to that level.
You might want to checkout a product called FMDataGuard and the link to their site is http://www.worldsync.com/ . I spent some time integrating this product into a workflow application for a client. It did take some time to setup and testing a process such as auditing is always important. From what I understand, the plug-in that is required is doing an internal SQL related action within FileMaker to track changes and deletes.
Another option is to roll your own auditing solution is to use scripts and custom functions. Many times, you can run multiple types of auditing in your solution. The SuperLog technique (a free custom function from NightWing Enterprises) is a great way to audit record changes but does not log delete activity. You could script a delete process that moves deleted records to a holding area.
I had heard or read somewhere that someone had commented that there was a recent explosion in FileMaker auditing products but I haven’t noticed that myself. If there is a reader out there with more details about auditing options, please feel free to send me an email.
Here are some links to other posts that might be of interest in regards to auditing...
A Quick And Easy Audit Log
Current Examples Of Some Custom Functions I Use
Disable Access To The Window Menu
Salvaging Data After A Very Hard Crash
ABOUT NETWORKING A FILEMAKER SOLUTION
Depending on the number of users you plan to have for your FileMaker solution, you can have a user share up to 5 databases to 10 total users, you can purchase space on a database hosting service or purchase a copy of FileMaker Server.
Purchasing space from a FileMaker hosting company is a very low cost method to share a database to many users from multiple locations. Purchasing FileMaker Server gives you more direct control of the sharing and backup processes.
More info about the author and FileMaker in general, contact me at firstname.lastname@example.org.
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