Designing & Evaluating 21 CFR 11 Compliant Access Databases

Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Many drug and device firms find that Microsoft Access is a perfect software package for database management with familiar, easy-to-use features, good functionality and smooth integration with other common software. But what should you do to be sure your Access databases are Part 11 compliant? FDA requires evidence of your validation efforts, and regulated industry routinely sees the consequences of non-compliance-–every year, hundreds of 483s and warning letters are issued to companies who did not design or validate their databases to meet these requirements. If you’re using Microsoft Access for your databases, you have very specific Part 11 concerns, and you need to take special care to ensure you have the appropriate audit trails, security, and electronic signature requirements in place.

The following topics will be covered in detail:

• Learn what the FDA will look for during audits
• How to define requirements quickly.
• How to document inputs, code and security settings.
• Details on when and where to use electronic signatures.
• Inactivity timeouts, and controls for users and passwords.
• Managing change control and common change control mistakes to avoid.

On Tuesday, January 10, 2012 at 1:00 EDT, join FOI Services and Ofni Systems for a 90-minute teleconference to gain practical knowledge about desktop database compliance and validation, including specific, practical advice on creating compliant desktop databases, validation methodology and maintaining desktop databases in GxP environments.

About Ofni Systems

Ofni Systems is an industry leader for 21 CFR Part 11 compliance. Their products for Part 11 compliant databases and spreadsheets are used by pharmaceutical, biotech, and medical device companies across the globe, while it’s products for computer validation, auditing, and FDA submissions ensure that their clients meet every requirement for electronic records and electronic signatures. The company provides live desktop support for superior customer support and training and has been providing solutions to their clients since 1999. For more information, call (919) 844-2494 or visit www.OfniSystems.com.