Daniel Waterman 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 Daniel Waterman 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 Daniel Waterman

Daniel Waterman is the Validation Manger for Ofni Systems, Inc., a software provider and Part 11 consulting firm. He has a strong background in software compliance and computer system validation. Daniel has managed numerous spreadsheet validation projects for clinical, laboratory and quality groups. Daniel has more than a decade of experience working for and consulting to FDA-regulated companies, including compliance and validation training, managing validation projects and assisting companies to develop and maintain procedures required for regulatory compliance.

Ofni Systems is a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal Validation Document Generator software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006.