Excel Spreadsheet Validation

Using MS Excel in GxP Environments

The FDA and other regulatory bodies require spreadsheets to be validated and compliant with 21 CFR 11. The FDA has recently focused more attention on the use of spreadsheets during compliance audits. (View sample warning letters relating to spreadsheets.)

Ofni Systems, a leader in spreadsheet validation, can ensure that your spreadsheets are compliant with all regulatory requirements.

Experts in MS Excel Compliance and Validation

A key validation requirement is compliance with 21 CFR Part 11. We use ExcelSafe, which provides MS Excel with audit trails, limited system access, password controls, and other technological tools.

Industry-leading Validation Methodology

Step 1: Gather Requirements. Document the spreadsheet functional requirements. Functional Requirements describe what the spreadsheet must be able to do. This includes:

• Worksheets and charts to be included on the workbook
• Data to be entered into the workbook
• Formulas or calculations used on each worksheet
• Identifying who can enter the data into the spreadsheet
• Identify how the spreadsheet meets applicable regulatory requirements

Step 2: Document design requirements. Design Requirements describe how the spreadsheet accomplishes the functional requirements. Ofni Systems uses proprietary tools to analyze spreadsheets to create comprehensive design specifications. Design specifications include:

• Inputs – Data entry ranges, validation rules, etc.
• Processing – Calculations, macros, etc.
• Outputs – Chart ranges, data exports, etc.
• Security – User level security, spreadsheet protection, etc.

Step 3: Develop and Execute Test Plans. Test plans are developed to demonstrate that all required spreadsheet functionality is met and the spreadsheet is properly secured.

Ofni Systems uses FastVal to perform spreadsheet validations, which allows us to complete validation projects in 70% less time than traditional validation methods.

View a sample Ofni System spreadsheet validation.

Special Trial Validation Offer

Ofni Systems will perform a free spreadsheet validation of one of your spreadsheets for qualified purchasers to demonstrate our validation method.

Additional Resources

Additional information is available on specific types of validation:

• Validating Computer Systems
  • Validating MS Access Databases
  • Validating MS Excel Spreadsheets
  • Validating Web Pages and Web Applications
  • Validating Mi-Co User Forms
  • Computer Software Validation
• Process and Equipment Validation
• Cleaning Validation