Commissioning and Qualification
Commissioning, DQ, IQ, OQ, PQ and requalification of facilities, utilities, production equipment, laboratory equipment and controlled-temperature units.
INTEGRATED GxP SERVICES
Qualification, Validation, Testing and Calibration Across the System Lifecycle
Labmerit provides integrated technical and compliance support for facilities, utilities, equipment, processes and computerized systems in regulated environments. Our services support key stages of the project lifecycle — from initial assessment, planning and risk analysis to execution, reporting, periodic review and revalidation.
Validation and Qualification
Risk-based qualification and validation of facilities, systems, equipment, manufacturing processes, cleaning procedures and computerized systems.
Process Validation
Risk-based validation of manufacturing processes and cleaning procedures, from strategy and protocol development to execution support, evaluation and final reporting.
Cleaning Validation
Risk-based validation of manufacturing processes and cleaning procedures, from strategy and protocol development to execution support, evaluation and final reporting.
Computerized Systems Validation
Risk-based validation of GxP computerized systems, including EMS, BMS, SCADA, ERP, WMS, LMS/LIMS, QMS and cloud-based applications.
Testing and Measurement
Technical testing, calibration, mapping and measurement services delivered through controlled methods and calibrated equipment. Accredited activities are performed only within Scopes 01-303 and 02-071; other specialized services are clearly identified as outside the accredited scope.
Testing
Accredited testing within Scope 01-303, together with clearly identified specialized services outside the accredited scope for controlled environments, HVAC systems, safety and containment equipment, utilities and process gases.
Calibration
ISO/IEC 17025-accredited calibration of temperature, relative humidity and pressure/vacuum instruments within Scope 02-071, performed in our laboratory or at the client’s location.
Temperature Mapping and Transport Qualification
ISO/IEC 17025-accredited temperature and humidity mapping within Scope 01-303, together with GxP qualification support for storage and transport systems outside the accredited scope.
Consultancy and Compliance
Planning, risk management and lifecycle documentation that connect regulatory requirements, engineering activities and quality oversight.
Validation Planning and GxP Consultancy
Development of risk-based validation strategies, master plans, user requirements, risk assessments, procedures and traceable lifecycle documentation designed to support audit readiness.
From Initial Assessment to Lifecycle Compliance Support
Assess
system scope, intended use, regulatory requirements and compliance gaps
Plan
requirements, risk assessments, validation strategy and protocols
Execute
qualification, validation, testing, calibration and documented evidence
Maintain
periodic review, requalification, revalidation, calibration and change support.
Not Sure Which Service Fits Your Project?
Tell us about your facility, system, equipment or compliance objective. Our team will help define an appropriate scope and coordinated project approach.
Contact Our Team