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Excel Validation

Ensure Compliance with Excel Spreadsheet Validation

Regulatory-compliant Excel validation that guarantees that all pharmaceutical calculations, reports, and vital business processes conform to GxP and other industry regulations to secure compliance.

Our Excel validation specialists combine the experience and knowledge of FDA-validated methodology with profound expertise in the pharmaceutical industry and take all GxP-critical workbooks to an FDA-controlled, FDA-audited, 21 CFR Part 11/Annex 11/GAMP 5 Cat 5-compliant level.

FDA-Validated Methodologies
Regulatory Compliance Focus
Pharmaceutical Expertise
Talk to an Excel Validation Consultant
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By the Numbers

Validation depth backed by
pharmaceutical expertise

Every engagement is backed by a track record that quality teams and auditors already trust.

500+

Projects executed

200+

Clients Supported

100+

Equipment & Utility Systems Qualified

24/7

Engineering Support
What is Excel Validation?

Understanding Excel Spreadsheet  Validation

Excel spreadsheet validation is a process of ensuring that GxP-critical workbooks, containing calculations, data analysis, batch records, stability data, and any other GxP-related information, generate reliable, consistent, and repeatable results.

 

Excel workbooks are considered computerised systems in accordance with FDA 21 CFR Part 11, EU GMP Annex 11 and WHO TRS 1019. Any Excel workbook, used for creating, calculating, storing or reporting any GxP data, needs to be validated and remain controlled during the entire lifecycle.

Excel Validation includes

Functional Requirements Analysis

Formula & Macro Verification

Version Control & Access Management

User Training & Support

Risk Assessment & GAMP Categorization

IQ/OQ/PQ Execution

Data Integrity (ALCOA+) Controls

Change Control & Revalidation

VALIDATION PROCESS

Trusted Excel Validation Consultants.

From requirements to release, every step is engineered for regulatory
compliance and data integrity.

Step 01

Requirements Gathering

Capture intended use, users, calculations and
regulatory drivers.

Step 02

Risk Assessment

GxP impact, complexity and failure-mode
analysis for each workbook.

Step 03

Validation Planning

Strategy, scope, deliverables and acceptance
criteria documented.

Step 04

Testing & Execution

Scripted IQ/OQ/PQ with evidence captured
against every requirement.

Step 05

Training & Support

Hand-over training and SOPs to keep the
sheet in validated state.

Step 06

Documentation & Release

Validation summary, traceability matrix and
controlled release.

Why It Matters

Spreadsheets are GxP systems too.

When a workbook drives a release decision, a calculation, or a regulatory record, it must be validated. We deliver inspector-ready evidence with minimal disruption to your team.

21 CFR Part 11 electronic records & signatures

EU Annex 11 alignment for computerised systems

GAMP 5 category-based validation rigor

ALCOA+ data integrity controls end-to-end

Reusable templates that accelerate future sheets

Key Capabilities

Validation depth across every spreadsheet.

Comprehensive Excel validation services backed by proven pharmaceutical
expertise.

Functional Requirements Analysis

  • Translate business needs into testable specs
  • Define intended use & user roles
  • Identify GxP-critical calculations
  • Document user requirements (URS)

Risk Assessment & GAMP Categorisation

  • GAMP Category 3–5 classification
  • Failure-mode analysis
  • Critical control point identification
  • Risk-based validation scoping

Formula & Macro Verification

  • Formula logic testing
  • VBA macro code review
  • Boundary & edge-case testing
  • Regression testing across updates

Comprehensive Testing Strategies

  • Positive, negative & boundary testing
  • Functional & regression testing
  • Scripted IQ/OQ/PQ execution
  • Evidence capture against requirements

Data Integrity Assurance

  • ALCOA+ controls
  • Electronic audit trails
  • Version control
  • Access & password restrictions

21 CFR Part 11 Compliance

  • Audit trails per 11.10(e)
  • User-level security per 11.10(g)
  • Electronic signatures (11.50, 11.100)
  • EU Annex 11 alignment

Complete Documentation Packages

  • FS & Risk Assessment
  • Validation protocols
  • Requirements traceability matrix
  • Validation Summary Report

User Training & Support

  • Role-based training
  • User manuals & SOPs
  • Change-awareness training
  • Ongoing user support

Change Control & Revalidation

  • Periodic review scheduling
  • Change impact assessment
  • Revalidation triggers
  • Version retirement process

Legacy Spreadsheet Remediation

  • Inventory & risk-rank existing sheets
  • Retrofit controls into legacy workbooks
  • Migration to validated templates
  • Documentation back-fill

Functional Requirements
Analysis

Translate business needs into clear, testable spreadsheet requirements.

Comprehensive Testing
Strategies

Positive, negative, boundary and regression testing across formulas and macros.

Regulatory Compliance
Expertise

Aligned with 21 CFR Part 11, EU Annex 11 and GAMP 5 category 5 guidance.

User Training & Support

Role-based training to keep validated state across users and revisions.

Risk-Based Validation
Approach

Effort scaled to GxP impact, complexity and intended use of each sheet.

Complete Documentation
Packages

URS, FS, RA, IQ/OQ/PQ, traceability and validation summary reports.

Data Integrity Assurance

ALCOA+ controls, audit trails, version control and access restrictions.

Ongoing Maintenance
Protocols

Periodic review, change control and revalidation triggers built in.

Spreadsheets We Validate

Coverage Across Every GxP Workbook

Pharma Calculations Grid
Batch Record Calculations
Stability Data Trending
Assay & Calibration Calculations
Environmental Monitoring Logs
Training Record Trackers
Yield & Reconciliation Sheets
Equipment Calibration Logs
Quality Metrics Dashboards
CAPA & Deviation Trackers
Raw Material Testing Sheets
Lab Data Reduction Sheets
Validation Master Schedules
Regulatory Frameworks

Validation Built Around Global Standards

FDA GMP

EU GMP

WHO TRS 1019 Annex 4

GAMP 5

PIC/S PI 011-3

ALCOA+ Principles

ISPE GAMP Categories

FDA CSA Guidance

MHRA Data Integrity Guidance

ICH Q9 Risk Management

Validation Project Phases

From Requirements to Controlled Release.

Comprehensive Excel validation services backed by proven pharmaceutical
expertise.

Planning

  • URS
  • Risk Assessment
  • GAMP Categorisation
  • Validation Plan

Design

  • Functional Specification
  • Design/Configuration Spec
  • Test Strategy
  • Acceptance Criteria

Build

  • Spreadsheet development & configuration
  • Macro & formula build-out
  • Peer review
  • Version baseline

Testing

  • Validation & Testing
  • Validation protocol
  • Evidence collection
  • Regression testing
  • Test documentation

Documentation

  • Traceability matrix
  • Test evidence review
  • Validation Summary Report
  • Deviation resolution

Release & Maintenance

  • Controlled release
  • User training
  • Periodic review scheduling
  • Change control

Functional Requirements
Analysis

Translate business needs into clear, testable spreadsheet requirements.

Comprehensive Testing
Strategies

Positive, negative, boundary and regression testing across formulas and macros.

Regulatory Compliance
Expertise

Aligned with 21 CFR Part 11, EU Annex 11 and GAMP 5 category 5 guidance.

User Training & Support

Role-based training to keep validated state across users and revisions.

Risk-Based Validation
Approach

Effort scaled to GxP impact, complexity and intended use of each sheet.

Complete Documentation
Packages

URS, FS, RA, IQ/OQ/PQ, traceability and validation summary reports.

Data Integrity Assurance

ALCOA+ controls, audit trails, version control and access restrictions.

Ongoing Maintenance
Protocols

Periodic review, change control and revalidation triggers built in.

Why Choose QIS

Why Leading Pharma Companies Choose Us

Specialized Spreadsheet Validation Expertise

Risk-Based, GAMP-Aligned Methodology

Reusable Templates That Accelerate Future Sheets

Practical Solutions for Real-World Excel Use

Clear, Structured, Audit-Ready Documentation

Legacy Spreadsheet Remediation Experience

Inspection-Ready Evidence, Minimal Disruption

Lifecycle Support From URS to Retirement

Deliverables

What You Receive

User Requirements Specification (URS)

Functional Specification (FS)

Risk Assessment Report

GAMP Categorisation Memo

Design/Configuration Specification

IQ/OQ/PQ Protocols & Reports

Requirements Traceability Matrix

Test Evidence & Screenshots

Validation Summary Report (VSR)

SOPs, User Manuals & Training Records

Compliance

Validation Designed for GxP Success

Every Excel validation engagement is developed to support:

21 CFR Part 11 Electronic Records & Signatures

EU Annex 11 Alignment for Computerised Systems

GAMP 5 Category-Based Validation Rigour

ALCOA+ Data Integrity Controls End-to-End

Audit Trail & Access Control

Inspection Readiness

Sustainable Revalidation Practices

Industries We Serve

Trusted across Regulated Sectors

Pharmaceutical Manufacturing

Biotechnology

Medical Devices

Quality Control & Regulatory Teams

CMOs

CDMOs

Life Sciences

Research Laboratories

Related Services

Explore More QIS Services

Computer System Validation
Pharma Engineering
GxP Applications
Project Management
Training Programs
Digital Training
Thermal Validation
Audit Services
FAQs

Frequently asked questions

What is Excel spreadsheet validation?
That is evidence of the fact that a GxP critical workbook works as designed every single time. That is verification of the fact that formulas, macros, access control and audit trail perform as expected and produce results which are reliable and reproducible per 21 CFR Part 11 and EU Annex 11 requirements.
No. Validation applies to spreadsheets that create, calculate, store, or report GxP data, or that feed a release, quality, or regulatory decision. Which workbooks fall in scope, and how hard they need to be tested, comes down to a risk-based GAMP assessment.
GAMP sorts spreadsheets on a scale, from Category 3 (basic, unconfigured calculations) up to Category 5 (custom macros and more complex code). Where a workbook lands decides how much testing, documentation, and change control it needs.
Yes, though it takes some work. Track Changes and other built-in features won’t get you there alone; they don’t meet Part 11’s audit trail requirements. Closing that gap takes access restrictions, electronic signatures, and a tamper-evident audit trail configured on top.
Excel validation applies CSV principles to one workbook’s formulas, macros, and configuration. Software validation is the bigger picture, covering purpose-built systems like LIMS, MES, or ERP. Both rest on the same GAMP 5 and 21 CFR Part 11 foundation; only the scale changes.
With positive, negative and boundary testing: ensuring that calculations yield correct results during normal usage, validating that the spreadsheet doesn’t collapse when subjected to invalid input data or extreme values, as well as regression testing when formulas and macros are modified.
Revalidation follows change, not a calendar. A formula edit, macro update, new Excel version, or shift in intended use should trigger a documented impact assessment. Most organisations also schedule periodic reviews to confirm the sheet is still sitting in its validated state.
Yes. We inventory and risk-rank existing spreadsheets, retrofit access controls and audit trails into older workbooks, and back-fill whatever documentation is missing so each sheet can stand up to an inspection.
Pharmaceutical manufacturing, biotechnology, medical devices, CMOs, CDMOs, and life sciences organisations more broadly, along with the quality control and regulatory teams who depend on Excel for GxP-critical work.
VALIDATION PARTNERSHIP

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Let our experts ensure your spreadsheets meet pharmaceutical regulatory requirements and maintain data integrity — end to end
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