The Clinical Device Group presented an e‑conference 21 CFR Part 11 Compliance and Validation for MS Access Databases on February 18, 2009. The e‑conference was presented by Mr. Tyson Mew. Ofni Systems provided a special free offer to all conference attendees.

This conference has already occurred. Please contact Ofni Systems if you would be interested in setting up your own training session on 21 CFR Part 11 Compliance or Validation of MS Access databases.

Learning Objective

By attending this conference, you will learn:

• How Part 11 requirements should be implemented in Access databases
• How to add audit trails and security quickly and easily to existing databases
• Advance techniques for adding Electronic Signatures, inactivity timeouts, and controls for users and passwords
• Strategies for how to document and validate Access programs:
• How to Define requirements quickly
• How to Document Inputs, Code and Security Settings
• Tips for efficient testing for any type of database

Addressing Validation

Mr. Tyson Mew will address validation and 21 CFR 11 with regard to usage of Access databases. 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:

• How to add audit trails to any part of the database
• How to properly secure the data and code
• Access database security settings for multiple users
• Common settings to apply to limit user actions
• Learn what the FDA will look for during audits
• Managing change control and common mistakes to avoid
• Details on when and where to use Electronic Signatures
• Database testing and techniques for software validation

Attendees will receive instructions for how to apply controls to their own access programs.  In additions, attendees may download sample code and validation documents for their own use.

This presentation will provide the instructions, materials and documentation to ensure full compliance with 21 CFR Part 11 for all new or existing MS Access databases.  By streamlining these compliance activities, organizations can make better use of these powerful data collection tools and save money that would have been spent purchasing inferior commercial products that don't match your existing requirements.

You will Receive

All people who attend this e-conference will receive:

• PowerPoint Slides.
• An expert speaker.
• A chance for Q&A.
• CEUs & Certificate.
• Free trial copy of software that can be added to their own databases.
• Sample MS Access database validation documents, including Requirements and Design Specifications, and also common test cases for inputs, audit trails and security testing.

Audience Suitability

This e-conference is suitable for:

• Clinical research professionals who design clinical trials
• Regulatory professionals who report clinical data
• Statistical professionals who analyze clinical data
• Non-statisticians interested in the subject
• Managers who sign-off on clinical trials
• Executives who are planning their companies futures

Register Now for 21 CFR Part 11 Compliance and Validation for MS Access Database

Special Offer from Ofni Systems

Ofni Systems will provide all conference attendees with a free trial copy of The Part 11 Toolkit. The Part 11 Toolkit provides security and compliance features for MS Access databases, including audit trails, user and group level security and electronic signatures. The Part 11 Toolkit also provides tools like a customizable search engine for system data.

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 and has worked on hundreds of client access programs to make them compliant. Mr. Mew regularly conducts training sessions for organizations to educate employees about the specific requirements of the rule and how to incorporate it into daily practices.  He is an active member of ISPE, DIA, PDA, SQA and the PEERS Group.