Case Study · Fictional teaching example

GxP Spreadsheet

Formula, rounding, boundary, protection, version, and independent-verification decisions for a release calculation.

Author
Sandip Thorat
Published
12 September 2026
Last reviewed
12 September 2026
Version
1.0
Content type
Practitioner guidance
Primary references
See related regulations, guidance, and approved procedures

Standard case study record

Scope and decision fields

Read these fields before the detailed worked case. All organizations, identifiers, test outcomes, and decisions are fictional teaching material.

GxP Assessment
The workbook calculates a finished-product result used in a regulated batch-disposition decision. Formula, input, version, protection, and review controls are GxP-relevant even though the workbook contains no macros.
Change or Issue
A copied formula references the previous row after a new product range is inserted, and rounding is applied before rather than after the final calculation.
Functions Affected
  • Controlled data entry
  • Formula and reference integrity
  • Rounding and unit rules
  • Independent verification and approved-copy control
Potential Impact
A batch near the acceptance limit could be reported as passing when the approved calculation would fail.
Deviations / Known Issues
The fictional boundary test detects a one-unit rounding difference. Release of the workbook is withheld until the formula is corrected, independently verified, and regression tested.

Situation

A controlled workbook calculates a finished-product result used by Quality during batch disposition. It has no macros. A new product range and a revised rounding rule are introduced.

Intended Use

Authorized analysts enter approved source values and the workbook calculates a result for qualified Quality review. The workbook does not import raw instrument data or approve the batch.

Failure Scenarios

  • A copied formula references the previous row.
  • Rounding occurs before the final calculation.
  • An analyst uses an uncontrolled local copy.
  • A protected formula cell is overwritten through an unlocked range.

Existing Controls and Evidence

The approved template is stored in a controlled location, formula cells are protected, a second analyst verifies the result, and prior known-answer tests are available. Those records do not cover the new product range or revised rounding rule.

Evidence Gaps and Testing Approach

Review every affected formula and reference. Execute independent calculations, exact known-answer cases, values immediately below, at, and above each limit, invalid and blank inputs, unit challenges, protection checks, version identification, save-and-reopen behavior, and controlled-copy retrieval. Record expected and actual values without masking precision.

Validation Conclusion

In this fictional case, a boundary test exposes premature rounding. The workbook is not released until the rule is corrected, independently verified, regression tested, and approved. Absence of macros is not used as the validation decision.

Reassessment Criteria

Reassess formula, lookup, range, rounding, unit, protection, platform, source-data, intended-use, or approved-location changes.