Spreadsheet Validation Training

GxP Computerized Systems should be compliant with regulations. Computerized Systems are clearly defined and Spreadsheets are regarded to be Computerized Systems as well. How Computerized Systems must to comply with regulations  is described in the ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems. However, many times this approach is too extensive for Spreadsheet validation.

To ease your life Rescop has developed Spreadsheet Validation training. During this training we will  teach you the specifics of applying Computerized System validation to Spreadsheets. This training combines the theory from the ISPE GAMP® 5 Guide with exercises to simulate the practical implementation.

The training is suitable for people who need to be aware or are responsible for Spreadsheet Validation. This training will take 1 day.

The Spreadsheet Validation training can be booked in our Open Classroom Schedule at one of our training locations, or as an In-Company training at your location.

Spreadsheet Validation Foundation

The Spreadsheet Validation Foundation training will include the theory from the ISPE GAMP® 5 Guide: Compliant GxP Computerized Systems, combined with the practical experience of our trainers and best practices from the industry. The foundation training is setup to teach trainees the basics of Spreadsheet Validation.

Topics regarding Spreadsheet Validation will be discussed, like: Spreadsheet Validation will be discussed, like:

  • Which types of Spreadsheets do we have?
  • Which Validation approach is required for which type of Spreadsheet?
  • How does Risk Management and Risk Assessment help to reduce the workload of validation?
  • How to test requirements?
  • How should Spreadsheets be secured for changes?
  • Which processes need to be covered during Spreadsheet Operation?

In what detail should documentation be developed?

Program Spreadsheet Validation Foundation

1 Day

  • Module 1 – Background
  • Module 2 – Terms & Definitions
  • Module 3 – Spreadsheet Classification
  • Module 4 – Requirements
  • Module 5 – Development
  • Module 6 – Creating Test Protocols
  • Module 7 – Test Execution
  • Module 8 – Operational Phase
  • Module 9 – Retirement Phase
  • Module 10 – Spreadsheet Inventory