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Excel Validation

Excel Sheet
 Validation

Comprehensive GxP application development and validation services that ensure regulatory compliance and data integrity across pharmaceutical systems and critical business processes.

FDA-Validated Methodologies
Regulatory Compliance Focus
Pharmaceutical Expertise
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Key Capabilities

Validation depth across
every spreadsheet.

Comprehensive Excel validation services backed by proven pharmaceutical
expertise.

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.

VALIDATION PROCESS

A systematic 6-step
approach.

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 QIS GXP

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

VALIDATION PARTNERSHIP

Ready to validate your Excel applications?

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