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Benefits of the Part 11 ToolkitTM

Large Corporations

Larger corporations may have hundreds or thousands of Access programs, and making even a fraction of them secure and compliant may be overwhelming. Wouldn't it be nice to know that all of your programs could be made compliant in a short period of time with a set of industry-tested tools, and once you learned how to use these tools, they would all work the same way? You can!

The Part 11 Toolkit can add a common set of controls to all of your programs for managing users and password controls, audit trails and electronic signatures, and even search engines. Once users are trained on one program with the Toolkit installed, they will immediately be familiar with any similar program and can start using the valuable information contained within each program. In addition, there are price discounts offered for larger sites, starting with as few as 5 copies of the program.

Small Businesses

We work with many small or start-up companies and know how difficult it can be to make large software investments. In addition, new technologies often require the use of custom-written software, and Access works quite well in these situations.

The Toolkit works extremely well in both of these cases. It can be applied to any existing MS Access databases that have been developed by your company, or it can be used as a base for building new custom applications that do exactly what you need, whether it's in the lab collecting test results or analyzing existing data to spot trends that can improve your process or procedures.

Developers

Update each program within a single day with all the tools you need for 100% compliance with the technical requirements of 21 CFR Part 11.

Information Technology

Gain access to a common set of controls that give a consistent level of performance and security for all of your Access programs.

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CDER indicating increased inspections for compliance with 21 CFR 11