Equipment Qualification

Equipment Qualification is a systematic and documented process of ensuring that any GxP-regulated equipment is installed, operates, and performs according to the approved User Requirements Specification (URS) while producing consistent, reliable, and compliant results.

1USFDA, EMA, WHO, TGA And CDSCO

2Detailed Protocol for Qualification with Execution

3Support for pharmaceutical, biotech, and emerging innovations

4Detailed Workflow with All Test Reports FAT, SAT and DQ

What is Equipment Qualification?

Equipment Qualification verifies that any GxP equipment is installed, operates, and performs according to approved requirements. It involves assessing design components, reviewing specifications, and validating performance under real operating conditions. This includes Design Specification review, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).

Importance of Equipment & Process Validation

Industries like pharmaceuticals, biotechnology, healthcare, and medical devices require Equipment Qualification to ensure consistency, reliability, and quality.

Why it matters:

Regulatory Compliance – Meets FDA, EMA, WHO, and international validation standards.
Risk Mitigation – Prevents system failures and quality deviations.
Quality Assurance – Ensures accurate and consistent product output.

What We Offer

Validation Protocol Development

We prepare tailored protocols that define scope, strategy, acceptance criteria, and testing methodologies.

Execution of IQ / OQ / PQ

We perform the complete qualification lifecycle: • Installation Qualification (IQ) • Operational Qualification (OQ) • Performance Qualification (PQ)

Factory & Site Acceptance Testing

We conduct FAT to verify equipment before shipment and SAT to confirm proper functioning after installation.

Comprehensive Documentation

We prepare traceable, audit-ready documentation including protocols, reports, findings, and corrective actions.

Training & Support

We train your team on equipment usage, maintenance, compliance, and troubleshooting.

Our Validation Process

Validation Master Plan (VMP)

We help create a comprehensive VMP outlining validation strategy, roles, and methodologies.

Design Qualification (DQ)

We verify that equipment design meets user requirements and regulatory standards.

Installation Qualification (IQ)

Ensures equipment is installed according to manufacturer specifications and requirements.

Operational Qualification (OQ)

Validates that equipment functions correctly under defined operating conditions.

Performance Qualification (PQ)

Confirms that equipment consistently performs under real production conditions.

FAT & SAT

Factory Acceptance Testing before shipment and Site Acceptance Testing after installation.

Documentation & Reporting

Complete audit-ready validation documentation, test results, and traceability.

Training & Ongoing Support

Ensuring long-term compliance, knowledge transfer, and troubleshooting support.

“Techvalio’s qualification services helped our facility achieve compliance effortlessly. IQ, OQ, and PQ were executed with exceptional professionalism.”

Rajesh Mehta

Manufacturing Head, BioPharm Ltd.

“Their end-to-end IQ, OQ, and PQ execution was flawless. All documentation was audit-ready and aligned with global regulatory expectations.”

Dr. Neha Bhandari

Quality Assurance Lead, Genova Biotech

“Techvalio’s FAT and SAT support saved us weeks of downtime. Their team identified issues early and ensured the equipment was fully compliant before go-live.”

Vikram Shah

Engineering Manager, PharmaCore Industries

“The validation protocols, traceability, and structured execution were beyond impressive. Our inspectors specifically appreciated their documentation style.”

Ritu Agarwal

Regulatory Affairs Manager, MedAxis Healthcare

“From DQ to PQ, Techvalio provided exceptional clarity and technical expertise. Their team made the entire qualification lifecycle smooth and fully compliant.”

Karan Patel

Operations Head, Lifecare Biosolutions

FAQs

What is the sequence flow for Equipment Qualification?

The standard flow is: 1. User Requirement Specification (URS) 2. Design Qualification (DQ) 3. Factory Acceptance Test (FAT) 4. Installation Qualification (IQ) 5. Operational Qualification (OQ) 6. Performance Qualification (PQ) 7. Documentation & Release

What standards does Equipment Qualification follow?

We follow FDA 21 CFR Part 11, EU Annex 11, WHO, GAMP5, and other global guidelines.

Do you provide process validation along with equipment qualification?

Yes, we offer complete process validation including DQ, PPQ, and ongoing revalidation.