Part 11 Compliance for your Access Database

MS Access--A Relational Database
Hundreds of 483's and warning letters are received each year by companies who did not design or validate their Access databases to Part 11.

Learning Objective
In this e-conference you will learn how to implement Part 11 requirements in an MS Access database.

Mr. Mew Will Cover
This presentation will provide the instructions, materials and documentation to ensure full compliance with 21 CFR Part 11 for Access databases. Mr. Mew will address:
[x] Strategies for how to document and validate Access programs.
[x] How to define requirements quickly.
[x] How to document inputs, code and security settings.
[x] How to add audit trails to any part of the database.
[x] How to properly secure the data and code.
[x] Access security settings for multiple users.
[x] Common settings applied to limit user actions.
[x] Details on when and where to use electronic signatures.
[x] Managing change control.
[x] Common change control mistakes to avoid.
[x] Advanced techniques for adding electronic signatures, inactivity timeouts, and controls for users and passwords.
[x] Tips for efficient database testing.
[x] What FDA looks for in data audits.

Keep It Secure for Greater Benefit
By properly securing your databases, you can allow a much wider audience to use and benefit from every database in your organization.

You will receive
[x] PowerPoint Slides.
[x] An expert speaker.
[x] A chance for Q&A.
[x] CEUs & Certificate.
[x] A free trial copy of software that can be added to your own databases.
[x] Sample Access database validation documents, including requirements and design specifications, common test cases for inputs, audit trails, and security testing.

Audience suitability
[x] Anyone who designs case report forms.
[x] Anyone who designs databases in MS Access.
[x] Regulatory professionals who must defend the compliance of databases.
[x] Quality professionals who may audit the database.
[x] Managers and staff who are responsible for providing valid data.
[x] Information technology professionals who with clinical research functions.

Presenter
Tyson M. Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. He is the creator of the Part 11 Toolkit for MS Access.

The purchase is $424 for OnDemand access and $474 itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.