Equipment Validation

Introduction: What Is Equipment Validation?

Equipment validation is the documented process of ensuring that any instrument, machine, or system used in manufacturing, testing, or quality control consistently performs as intended, meeting predefined criteria for accuracy, reliability, and compliance. In regulated industries such as food, pharmaceuticals, biotechnology, and medical devices, equipment validation is not optional t is a regulatory requirement to guarantee product quality and consumer safety.

At Eurofins, we provide comprehensive validation services that ensure equipment is compliant with global standards, operates reliably, and supports the integrity of your data and products.

Why Equipment Validation Must Be Done

At Eurofins, we recognize the importance of equipment validation for:

Regulatory Compliance: Meeting requirements from agencies such as FDA, EMA, WHO, and FSSAI.
Product Safety & Quality: Ensuring consistent and reproducible results to safeguard consumer health.
Data Integrity: Preventing errors, deviations, or unreliable test outcomes.
Risk Mitigation: Reducing chances of equipment-related failures, recalls, or non-compliance penalties.
Operational Efficiency: Minimizing downtime, enhancing process control, and extending equipment lifespan.

Types of Equipment Validations We Offer

Eurofins offers end-to-end validation services across industries with globally harmonized protocols.

Design Qualification (DQ): Verifying equipment is designed to meet intended purpose and regulatory requirements.
Installation Qualification (IQ): Ensuring equipment is delivered, installed, and configured correctly.
Operational Qualification (OQ): Confirming equipment operates within specified limits under controlled conditions.
Performance Qualification (PQ): Demonstrating consistent performance in real-world operating environments.
Re-Validation & Periodic Checks: Required after relocation, modification, or maintenance to maintain compliance.

Regulatory Requirements for Equipment Validation

Aspect	FSSAI (India)	European Union
Regulatory Body	Food Safety and Standards Authority of India (FSSAI)	European Medicines Agency (EMA), EU Commission
Applicable Sectors	Food safety testing equipment	Pharmaceuticals, Medical devices, Food safety
Validation Standards	National/international guidelines; RAFT scheme	EU GMP Annex 15; MDR 2017/745; IVDR 2017/746; ISO standards
Validation Stages	Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)	Design Qualification (DQ), IQ, OQ, PQ
Validation Process	Single lab validation + collaborative ring trials for RAFT kits	Continuous lifecycle validation including re-validation
Required Documentation	Validation reports, technical specs, safety certificates, user manuals, AMC plans	Technical dossiers, design documentation, installation records, operational logs
Equipment Safety Standards	IEC 60601, IEC 61010 electrical safety certifications	Compliance with EU safety directives, CE marking requirements
Post-validation Support	After-sales service, calibration, maintenance, AMC	Ongoing monitoring, maintenance, re-validation, QMS adherence
Approval Process	Online RAFT portal for validation and approval of rapid test kits	CE marking, Notified Body assessment for higher risk devices

How Our Validation Process Works

At Eurofins, we follow structured and globally harmonized validation protocols:

Assessment & Planning: Risk analysis, equipment mapping, and protocol preparation.
Qualification: Execution of DQ, IQ, OQ, and PQ with clear documentation.
Calibration & Verification: Using traceable standards and certified reference materials.
Documentation & Reporting: Comprehensive reports with deviations, corrective actions, and compliance evidence.
Re-Validation & Training: Support for periodic checks, staff training, and audit preparedness.

Industries We Serve

Our validation services are essential for:

Food & Beverage Manufacturing
Pharmaceuticals & Biotechnology
Medical Devices & Diagnostics
Cosmetics & Nutraceuticals
Environmental & Chemical Testing Laboratories

Common Issues We Help Clients Solve

Issue	How Eurofins Helps
Non-compliance during audits	Full validation documentation, audit support, deviation closure
Equipment downtime or failures	Preventive maintenance & re-validation protocols
Incomplete or outdated SOPs	Development & harmonization of SOPs with validation data
Regulatory inspections or recalls	Technical support, re-validation, and compliance evidence

Case Study: Supporting a Pharmaceutical Manufacturer

A leading pharmaceutical manufacturer preparing for a US FDA inspection partnered with Eurofins to validate its HPLC, GC, and dissolution testing systems. Our team performed IQ/OQ/PQ protocols using certified standards, identified calibration gaps, and updated documentation. The client successfully cleared the FDA inspection with zero major observations.

Why Choose Eurofins for Equipment Validation?

Global Network: 900+ laboratories across 50+ countries.
Regulatory Expertise: Deep understanding of FDA, EMA, WHO, FSSAI, and ISO requirements.
State-of-the-art Facilities: Advanced calibration tools and certified reference standards.
Qualified Experts: Validation engineers, chemists, and QA specialists.
Comprehensive Services: From single-instrument validation to full plant-wide qualification.
Partner with Eurofins to ensure your equipment is compliant, reliable, and audit-ready.
Contact our validation experts today for consultation and tailored solutions.
Schedule your equipment validation now to ensure uninterrupted operations and regulatory confidence.
“Equipment validation is not a one-time activity it follows a lifecycle approach from design to retirement.”

Enquire now: www.eurofins.in/food-testing/enquire-now/