Spreadsheet Validation: 21 CFR Part 11 Compliance – 9/1/2010

Software intended for the management of manufacturing processes and FDA submissions may very well be too complex, expensive, and laden with features unnecessary in your environment. Commonly available spreadsheet programs like MS Excel may really be most appropriate – but how can you create, validate and use off-the-shelf programs in your regulated environment without violating the provisions of Part 11?

FDA is well aware of the wide utility of spreadsheets, but expects the controls to be in place to ensure that spreadsheets used in GxP processes are validated and compliant with 21 CFR Part 11. In today’s environment of renewed FDA enforcement of Part 11, uncontrolled spreadsheets represent an area of increased regulatory concern and scrutiny.

You can learn to confidently harness the versatility and functionality of spreadsheets. You, your colleagues and your organization can take advantages of all of the benefits of the ease-of-use and economy spreadsheets offer – and still remain in compliance with FDA’s regulatory requirements. Key points that will be covered include:

• How to design your spreadsheets to facilitate compliance and validation
• The part of a spreadsheet with the highest regulatory risk – and how to address it
• How FDA validates their own spreadsheets
• The expected contents of a spreadsheet validation package
• How to write spreadsheet requirements and specifications to facilitate good testing
• What must be included during spreadsheet validation testing
• The most common deviations discovered during spreadsheet validations, and how to focus your testing to detect these common mistakes

Presented by Ofni Systems, Validation Manager, Ofni Systems
Teleconference, Presented by FOI Services