Microsoft Access can be brought into compliance with 21 CFR Part 11 using a variety of 3rd party software tools.

Our recommended tools are from leading software suppliers for ensuring Access database compliance for 21 CFR Part 11 in pharmaceutical, clinical research and life sciences companies.

We select best in field suppliers and tailor our recommendation to your specific needs. Our current recommended and supplied software options are from Ofni Systems and Cimcon.

These tools vary in the way they work and also in the way they are priced.

• Ofni Systems Part 11 Toolkit is built into your existing database.
• Cimcons E-Infotree Access Desktop provides a secure environment into which your database is installed.

Both options allows customers to continue to use their own Access databases within a secure and audit trailed 21 CFR Part 11 compliant environment.  Both tools are proven to ensures data integrity and datbase compliance for all your laboratory and medical device databases.

CSV Compliance provides the software options and associated services to ensure Part 11 Compliance.  In addtion, we can combine the software with our validation documentation and quality assurance procedures.

As a result of using our recommended software options you’ll have the following benefits:

• Your regulated data is ready to pass inspection.
• Maintains your Access user base and your existing Access databases.
• A pre-prepared validation and testing package allowing immediate roll-out and implementation.
• Full audit trail of user inputs and manipulations.
• Use of electronic signatures for reporting results and data.