Validation and Use of Excel Spreadsheets in FDA Regulated Environments
In this session you will learn procedures and practices on how to validate and use Excel® requirements, and how to design spreadsheets for compliance, also how to ensure and validate spreadsheet integrity.
February 22, 2021
10:00 AM PST | 01:00 PM EST
More Trainings by this Expert
Product Id : 503526
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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
Areas Covered in the Session:
- The Lab compliance documents
- 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:
- Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley
- Recommendations from the new GAMP® 5 and EU Annex 11
- How to design spreadsheets for compliance
- How to 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
- Everybody developing Excel Worksheets for Regulated Environments
- QA Managers and Personnel
- QC Managers and Personnel
- Analysts and Lab Managers
- Validation Groups
- Validation Professionals
- Training Departments
- Documentation Department