Validation and Control of Excel® Spreadsheets in Regulated Environments

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® requirements can be met. For example, the FDA is widely using Excel® and complies with its own regulations.

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

Areas Covered in the Session :

• Regulatory requirements for spreadsheets; FDA Part 11 and GxP
• Recent FDA inspectional observations and warning letters
• Recommendations from the new GAMP®5 and EU Annex 11
• How to design spreadsheets for compliance.
• How to design, ensure and validate spreadsheet integrity.
• When, what and how much to test?
• Validation of standard/native Excel functions?
• How to apply risk based validation to spreadsheet applications
• Validation of ‘ad hoc’ spreadsheet applications.
• How to document planning, specifications, installation, testing and changes
• Examples from manufacturing, laboratories and offices

Who Should Attend:

• Everybody developing and using Excel Worksheets for regulated environments
• Developers and users of spreadsheet templates
• Lab Supervisors and managers
• QA managers and personnel
• QC managers and personnel
• IT managers and personnel
• Analysts and lab managers
• Validation groups
• Training departments
• Documentation department
• Consultants
• Teachers

Course Director: DR. LUDWIG HUBER

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), 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”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).