Q: How do I know the Part 11 Toolkit will work with my database?
A: The Part 11 Toolkit has been available for 8 years and installed on hundreds of databases. We have never received an Access database where the Toolkit could not be successfully installed. We would be happy to give you a free demonstration, using your database.
Q: How long does it take to install the Part 11 Toolkit.
A: Most Toolkit installations can be performed in one business day.
Q: We are still in the development process and our application changes continually. Can I continue to modify my application after the Toolkit is applied to it?
A: Yes. The developer still has 100% control of the database, including the ability to make changes or add new functionality.
Q: After validating the completed application, can I continue to add read only objects such as reports?
A: This is entirely dependent on the policies of your company. The addition of read only objects such as reports will not affect data integrity, but the decision to allow changes of any sort to the application is between the developer and whoever the authority for such actions is within your company.
Q: Is there anything added to the registry or on the desktop of the client computer?
A: There is nothing about the Toolkit that needs to be referenced on the client machine, either in the registry or placed on a local drive. The client computer will need to have MS Access properly installed just as it would for running the application without a Toolkit applied to it.
Depending on how your application is rolled out to the end users, it is not uncommon that the developer will wish to add a shortcut on the users' computer, but this is not a requirement.
Q: Can the toolkit be used with a MS SQL Server back-end?
A: Yes, a version of the Toolkit is available for use with a MS SQL Server back-end data source.
Q: Can the Toolkit run on a network? Can the Toolkit run on a local drive?
A: The Part 11 Toolkit can run on either a network location or from a local drive.
Q: Does the Part 11 Toolkit make my Access data completely compliant with 21 CFR 11?
A: The Part 11 Toolkit does provide Access with all of the technological tools for an Access database to be compliant with 21 CFR 11, but there are additional procedural controls, including validation, training and document control which are also required.
Q: Can you validate our Access database?
A: Absolutely. Ofni Systems has several proprietary tools to analyze your Access database and we use FastVal to facilitate the validation process. We can complete most Access database validations in a few weeks.
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