Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar By GobalCompliancePanel

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar By GobalCompliancePanel

Overview: 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 the Labcompliance 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

Areas Covered in the Session: Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.

Recommendations from the new GAMP5 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

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