21 CFR Part 11 Compliance and Validation for MS Access Databases – 3/8/2012

Ofni Systems will address validation and 21 CFR 11 with regard to usage of desktop databases, such as MS Access. Hundreds of 483s and warning letters are received each year by companies who did not design or validate their databases and spreadsheets to meet Part 11 requirements. By properly securing your databases, you can allow a much wider audience to use and benefit from every database within the organization.

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, March 8 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.

Audience Suitability

• Managers and staff who are responsible for providing valid GxP data for databases
• Anyone who designs desktop databases for use in GxP environments
• Regulatory professionals who must defend the compliance of desktop databases
• Quality professionals who may audit desktop databases or are responsible for administrating procedural requirements required for spreadsheet compliance
• Information technology professionals responsible for administrating files or network locations storing desktop databases containing GxP data
• Computer validation professionals working with desktop databases for use in GxP environments
• Executives who are planning their company’s futures

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.