Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel
14 Dec 2010
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.
Areas Covered in the Session:
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
Who Will Benefit:
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
Consultants
Past Events
Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel - 14 Dec 2010, Webinar (9506)
Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel 2026
Important
Please, check "Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel" official website for possible changes, before making any traveling arrangements
