Source: http://www.labcompliance.com/seminars/audio102/default.aspx
Timestamp: 2017-05-30 01:28:19
Document Index: 706841250

Matched Legal Cases: ['art11', 'art 11', 'art 11', 'art 11', 'art11', 'art11']

Using Excel® in Part11/GxP Regulated Environments
On-line Audio Seminar 102
Spreadsheets like Excel® are frequently used in regulated laboratories and production environment. Some companies have thousands of them. They need to be validated and comply with 21 CFR Part 11 and other regulations. The question is how, because Excel was not designed for part 11 and 'out of the box' Excel does not have all the functions as required by part 11. And spreadsheets applications are readily available, easy to program, and easy to change. Questions are:
Should we test standard Excel functions?
Standard Excel does not have part11 compliant audit trail, what to do?
Everybody can easily access Excel applications, how to ensure data security and integrity?
How to prevent that somebody changes the Excel spreadsheet?
Solutions will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.
FDA and EU requirements for Excel applications - What do inspectors asks and what documents should be available
Developing a culture and infrastructure for Macros&Spreadsheet compliance
Learn how to design and program Excel spreadsheets with quality and compliance in mind
Validation of Macros and Spreadsheet application during development, installation and on-going use
How to ensure security and integrity of spreadsheet applications?
Which (hidden) Excel functions are available to assist compliance?
SOPs: Validation of spreadsheets and other computer applications, GxP and part11 training Gap analysis for Macros and Spreadsheet applications
Spreadsheet validation project schedule
Draft article to be published in Biopharm: Using Macros and Spreadsheets in Regulated Environment FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Excel