Excel Spreadsheet Validation
An Excel spreadsheet may seem simple, but when it contains calculations that impact release decisions, it becomes a regulated computerized system.
Critical spreadsheets under regulatory control
Many pharmaceutical organizations rely on Excel spreadsheets for critical GxP calculations: stability, batch yield, quality control, weighing. When these spreadsheets feed into product release decisions, they become computerized systems that must meet the same regulatory requirements as any validated software.
At DRP Assurance we validate Excel spreadsheets under the GAMP 5 framework, 21 CFR Part 11 and EU Annex 11, ensuring that every formula, every calculation and every data point is correct, traceable and auditable.
Key Benefits
GxP impact assessment
We determine whether the spreadsheet affects product quality or data integrity.
GAMP 5 categorization
We classify as Category 3 (no macros) or Category 4 (with macros/VBA).
Formula protection
We ensure that critical calculations cannot be altered without change control.
Complete traceability
Version tracking, access control and audit trail of modifications.
21 CFR Part 11 compliance
When the spreadsheet is a GxP record, we ensure electronic signatures and controls.
Tailored IQ/OQ/PQ validation
Test protocols specifically designed for the Excel spreadsheet environment.
Our Process
Inventory and GxP assessment
We identify all critical spreadsheets and assess their impact on quality.
Categorization and validation plan
We classify per GAMP 5 and design the specific validation strategy.
Specification and design
We document URS and functional specification (for spreadsheets with macros/VBA).
Protocol execution
Installation, operation and performance testing with test data and boundary cases.
Report and maintenance
Validation Summary Report and change control procedure for future versions.
Service Features
Regulatory Framework
- FDA 21 CFR Part 11 — Electronic records
- EU Annex 11 — Computerized systems
- GAMP 5 (2nd Ed.) — Categories 3 and 4
- ICH Q9 — GxP risk management
- ANMAT Disposition 2673/1999
- WHO Technical Report Series
Deliverables
- GxP impact assessment
- Specific Validation Plan
- Requirements Specification (URS)
- IQ/OQ/PQ test protocol
- Change management (change control)
- Validation Report (VSR)
Why choose DRP for Excel Spreadsheet Validation?
Regulated Excel specialists
We don't treat spreadsheets as generic software. We understand the particularities of the Excel environment in the pharmaceutical industry.
Risk-based approach
We prioritize validation effort based on the actual GxP impact of each spreadsheet, optimizing resources.
Knowledge transfer
We train your team to maintain and version validated spreadsheets autonomously.
Can your Excel spreadsheets withstand an audit?
Find out if your critical spreadsheets meet regulatory requirements.
REQUEST GxP ASSESSMENT