Spreadsheets are commonly used to support all types of activities in a manufacturing or laboratory environment. The ease of using spreadsheets feeds the number of spreadsheets that are developed within an organization. How does this impact you from a compliance point of view and what needs to be done to address compliance requirements?

Rescop can help in clarifying these questions and other IT compliance issues. Our phased approach to spreadsheets enables you to inventory and classify your spreadsheets. If needed we can adjust your spreadsheets to meet compliance requirements (e.g. audit trail, security) and support you with the spreadsheet validation.

  1. Inventory and classify: Based on an enterprise scan spreadsheets are identified. After an initial shift we classify the remaining spreadsheets based on various aspects (e.g. GxP criticality) and an assessment on the future use of the spreadsheet. Remaining applicable spreadsheets feed back to your Validation Master Plan;
  2. Analyze and update: Rescop will analyze your spreadsheet and where necessary adjust the spreadsheet to meet applicable compliance requirements (security, audit trail);
  3. Validate and manage: Spreadsheets are validated and a System Management Plan is drawn up to ensure the validated state of the spreadsheet.

Depending on the current status we can support you in the various stages of spreadsheet validation or on specific activities within quality validation. Spreadsheets are the most commonly used kind of End User Applications, but our approach can also be applied to other types (e.g. databases). Please contact us, so we can determine the best way how to support you in compliance management.