Validation & Qualification (V&Q) is a core engineering discipline that ensures equipment, systems, and processes operate consistently, safely, and in alignment with regulatory standards. Fusion provides end-to-end validation support across automation systems, utilities, manufacturing equipment, laboratory instruments, and production processes for regulated environments such as pharmaceuticals, biotechnology, medical devices, and high-precision manufacturing.
Our teams combine engineering expertise with documentation accuracy and compliance-driven workflows. We ensure that every installation, operation, and process meets the intended design requirements and withstands audit scrutiny from regulators, certification bodies, and internal quality organizations.
Fusion follows a structured, industry-standard validation lifecycle built around clear documentation, technical rigor, and traceability.
Every engagement begins with creation or review of a Validation Master Plan (VMP) that defines scope, system classification, applicable regulations, and required validation deliverables. We perform risk assessments (FMEA, hazard analysis, impact analysis) to prioritize critical components and define depth of testing.
This ensures validation activities are efficient, risk-based, and aligned to regulatory expectations.
We support development, review, or refinement of URS and FRS documentation to clearly state how a system should perform and under what conditions.Well-structured URS/FRS documents reduce ambiguity, shorten qualification time, and support consistent testing during OQ and PQ.
Fusion engineers review system design documents, vendor specifications, wiring diagrams, software logic, and material compatibility to verify that the selected system is suitable for its intended use.Our DQ process examines:
Fusion engineers review system design documents, vendor specifications, wiring diagrams, software logic, and material compatibility to verify that the selected system is suitable for its intended use.Our DQ process examines:
Fusion’s OQ process includes:
IQ ensures that equipment or systems are installed correctly, safely, and according to manufacturer specifications, design documents, and regulatory requirements.
Fusion’s IQ work includes:
We generate all IQ protocols, execute testing onsite, record deviations, and compile IQ reports aligned with client SOPs and quality management systems.
IQ ensures that equipment or systems are installed correctly, safely, and according to manufacturer specifications, design documents, and regulatory requirements.
Fusion’s IQ work includes:
We generate all IQ protocols, execute testing onsite, record deviations, and compile IQ reports aligned with client SOPs and quality management systems.
OQ verifies that the system performs as intended across defined operating ranges and functional conditions.
Fusion’s OQ process includes:
We document all testing steps, evidence, and deviations using traceable templates suitable for FDA, ISO, and internal audits.
We ensure that any failure, deviation, or out-of-spec result is investigated through root-cause analysis and corrected before moving into PQ.
PQ ensures that the equipment or process consistently performs under real operating conditions and typical production scenarios.
Our PQ activities include:
PQ demonstrates real-world operability, stability, and capability, ensuring the system is fit for commercial use.
Fusion supports TMV to ensure laboratory and production test methods produce consistent, accurate, and reproducible results.
Our TMV activities include:
This is essential for labs, QC functions, and any environment where measurements impact release decisions.
For digital systems such as MES, SCADA, PLC, IIoT platforms, LIMS, and automation software, Fusion executes CSV aligned with GAMP 5 and 21 CFR Part 11 principles.
Our CSV work includes:
Fusion produces and maintains all validation documentation, including:
All documents follow audit-ready, traceable, version-controlled formats compatible with regulated industries.
Fusion provides validation for a wide range of assets:
Manufacturing & Production
Laboratory & Quality
Digital & IT Systems
Clients benefit from:
Fusion’s validation teams ensure operational continuity and regulatory confidence — enabling clients to manufacture safely, reliably, and efficiently.
We provide capability, problem-solving, and services — with speed and cost-efficiency at the core
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