Using Vault for Document Control

[astorm65]

Hello, I currently use Vault for our source control needs and have a question from our Compliance department about using it for some document control tasks. We have Excel files that our software uses and we need to track changes to these files. So... 2 questions, is creating a new repository for documents in our Vault system a good way to go? Or do I tell them that they really need to look at a full blown document management system? (we are a small group and the number of documents is less than 50) Next, they have ask that if we consider using Vault, is it Part 11 Compliant.

Thanks for any help here.

Alexandra Storm

[Beth]

You can certainly use Vault for document control if you wish. Excel files can be added to Vault using the Vault GUI client, and every check-in would be tracked like any other file. The difference is that Excel files are binary files, so you wouldn't be able to perform merges on them or use the Show Differences function. Giving the other department their own repository would help with managing security and performance.

As far as the Part 11 Compliance is concerned, we have not reviewed what the requirements are nor analyzed our software for that. Also, the information I found states that a software vendor can't claim they are Part 11 Compliant. See this article here: http://www.21cfrpart11.com/pages/faq/index.htm.

[astorm65]

Thank you so much for your response. That is very help for determining if Vault could be a solution for us, and the Part 11 compliance information is useful as our QC department needed to know this.

[Beth]

Feel free to ask us any further questions that would help you determine if we fit your needs.