Practitioner template
Spreadsheet Assessment
Assess the GxP use, formulas, data, protection, independent verification, change control, and periodic review of a spreadsheet.
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- Workbook and owner
- Intended use
- GxP record or decision
- Inputs and sources
- Calculations and rules
- Outputs and acceptance limits
- Formula and input protection
- Access and version control
- Independent verification
- Boundary and error testing
- Change control and incidents
- Conclusion and periodic review
Completed fictional example
Fictional teaching example: This is not an executed or approved validation record.
- Workbook and owner
- Fictional Product Acceptance Calculator; Quality Control
- Intended use
- Calculate a finished-product result for batch review
- GxP record or decision
- Result supports batch disposition
- Inputs and sources
- Three approved laboratory values and product range
- Calculations and rules
- Weighted calculation with final-step rounding
- Outputs and acceptance limits
- Pass or fail with retained full-precision result
- Formula and input protection
- Locked formula and lookup cells; controlled input ranges
- Access and version control
- Approved read-only template location with edit-owner restriction
- Independent verification
- Second analyst calculation for each release result
- Boundary and error testing
- Known-answer, below/at/above limit, blank, invalid, unit, and precision cases
- Change control and incidents
- Formula, range, unit, platform, or protection changes require assessment
- Conclusion and periodic review
- Released after rounding correction; annual or event-driven review