Spreadsheets just might be the most prevalent user-created software applications in business today. They’re quick and easy to create, and they’re useful not only for crunching numbers, but also for tracking data. But, when and how should you validate these tools?
You might have heard that ‘spreadsheets can’t be validated’ or ‘spreadsheets can’t be compliant’. However, this is not true. In this session, we’ll cover spreadsheet design, usage, and testing guidance provided by the FDA and international regulators. We’ll also review how standard validation and risk management concepts apply to spreadsheets.
If you’ve ever tried to apply a typical SDLC (software development life cycle) and/or validation approach to a spreadsheet, you probably found that your ‘quick and easy’ spreadsheet that you built in an afternoon took weeks or months to validate. This doesn’t need to be the case. In this session, we’ll show you a streamlined approach to spreadsheet documentation and validation that has withstood the scrutiny of regulatory inspections. We’ll walk through an example of a spreadsheet validation package, so you can see how to apply this approach. Then we’ll cover common spreadsheet compliance questions, such as ‘when is validation needed’ and ‘what about 21 CFR Part 11 compliance’. And finally, we’ll conclude the webinar with examples of FDA Warning Letters regarding spreadsheet validation, so you’ll know what not to do.
- Fundamental software validation and risk management terminology
- Key US and international regulatory guidelines regarding the use and validation of spreadsheets
- When does a spreadsheet need to be validated?
- Practical, risk-based approach to validating spreadsheets
- Applying 21 CFR Part 11 compliance requirements
- Streamlining validation documentation for spreadsheets
- FDA Warning Letters regarding spreadsheet