Spreadsheets are widely used across pharmaceutical operations (stability tracking, calculations, QC trending, dosing tables, equipment logs). When they support GxP decisions, spreadsheets must be validated to ensure accuracy, reliability, and data integrity. PrimeGMP provides targeted validation services for Excel workbooks and similar spreadsheet tools to ensure they perform as intended, preserve ALCOA+ principles, and meet regulatory expectations.

Why Validate Excel Sheets?

• Spreadsheets often contain critical calculations, pass/fail logic, and data used for release decisions.
• Errors in formulas, copy/paste mistakes, or uncontrolled edits can cause significant quality and regulatory risk.
• Regulators expect evidence that computerized tools used for GxP records are validated, controlled, and subject to change control.

Our Spreadsheet Validation Approach

1. GxP Impact & Risk Assessment

• Classify the spreadsheet (high / medium / low risk) based on business use and GxP impact.
• Conduct a risk assessment (ICH Q9 style) to define validation scope and test depth.

2. Requirements & Design

• Prepare a concise User Requirement Specification (URS) listing functional needs: inputs, outputs, calculations, reports, security, backup, and interfaces.
• Optional Functional Specification (FS) where complexity warrants (macros, VBA, linked sheets).

3. Control & Governance

• Recommend or implement controls: cell protection, locked sheets, protected workbook, validated macro signing, hide formulas where needed.
• Version control, filename convention, and an access/ownership matrix.
• Change control and approval flow for updates.

4. Test Planning & Execution (IQ/OQ/PQ style)

• Installation/Deployment (IQ): Verify correct file versions, folder structure, access rights, and backup location.
• Functional Testing (OQ): Execute test cases for each requirement — input validation, formula correctness, boundary conditions, error handling, macros behavior.
• Performance & Data Integrity (PQ): Run tests with representative datasets; verify outputs, reconciliation, and traceability to source data.

5. Data Integrity & Security

• Ensure data traceability (who changed what/when) using protected workflows or linked LIMS/DMS where applicable.
• Where electronic audit trail is required, recommend migration to a controlled system or implement manual audit records and change logs.
• Back-up, restore, and archival verification.

6. Documentation & Handover

• Provide validation plan, test protocols, executed test scripts with results, traceability matrix, risk assessment, and final validation report.
• SOPs: spreadsheet use, backup, change control, and periodic review procedures.
• Training for users and administrators.

Typical Tests & Examples

• Formula verification: cell-by-cell formula check and independent re-calculation.
• Lookup & link tests: VLOOKUP/INDEX-MATCH behavior when ranges change.
• Rounding and precision: boundary values and cumulative rounding checks.
• Macro/VBA validation: code review, signed macros, positive/negative flows, exception handling.
• Protection tests: verify locked cells, protected sheets, and password policies.
• Import/export & interface checks: consistent data flow with source systems (CSV, instrument exports).
• Stress / volume tests: large datasets, performance and calculation time.
• Reconciliation: compare final outputs with independent calculations or baseline data.

Deliverables

• Validation Plan & URS
• Risk Assessment & Traceability Matrix (requirements ↔ test cases)
• IQ Checklist (deployment verification)
• OQ Test Protocol & Execution Sheets (functional tests)
• PQ Report (operational use & data integrity checks)
• Final Validation Summary Report with conclusions & CAPA if any
• SOPs: Use, Backup/Restore, Change Control
• User Training Records and Acceptance Sign-offs

Regulatory & Good Practice

• GAMP 5 (Spreadsheet categorization & controls)
• 21 CFR Part 11 & EU Annex 11 (where electronic records/signatures apply) — recommend migration to validated computerized systems for audit trail needs
• ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
• ICH Q9 (Risk management) and EU GMP Annex 11 guidance

When to Recommend Full CSV vs. Spreadsheet Controls

• Full CSV recommended when spreadsheet drives release decisions, electronic signatures, or cannot meet audit trail requirements.
• For lower-risk spreadsheets, implement procedural and technical compensating controls: locked workbooks, change log sheet, versioning, supervisor review, and periodic revalidation.