Validation and Control of Excel® Spreadsheets in Regulated Environments education Blog
Validation And Control Of Excel® Spreadsheets In Regulated Environments Blog
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.
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
For easy implementation, attendees will receive
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 :
Developers and users of spreadsheet templates
Lab Supervisors and managers
QA managers and personnel
Target Companies :
Manufacturers of Pharmaceutical drug substances (APIs)
Medical device companies
For More Details:
Email: [email protected]