Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality.
Areas Covered in the Session:
FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
Learning from FDA warning letters related to spreadsheets
How to design spreadsheets for Part 11/GxP/Annex 11 compliance
Validation during design, development, installation and on-going use
When, what and how much to test?
For Easy Implementation, Attendees Will Receive
User Manual with Excel functions that help to comply with FDA requirements
SOP: Validation of spreadsheet applications
SOP: Development and use of spreadsheets in regulated environments
Gap analysis/checklist for Macros and Spreadsheet applications
Who Will Benefit:
Pharmaceutical and medical device industry
All developers and users of spreadsheet applications
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare".
Compliance4All DBA NetZealous,
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