Commissioning and Qualification
Commissioning, DQ, IQ, OQ, PQ and requalification of facilities, utilities, production equipment, laboratory equipment and controlled-temperature units.
GxP COMPLIANCE AND TECHNICAL SERVICES
Your GxP Partner for Qualification, Validation, Testing and Calibration
Labmerit provides integrated GxP support throughout the lifecycle of facilities, utilities, equipment and computerized systems. Our qualification and validation expertise is supported by ISO/IEC 17025 accredited testing and calibration laboratories.
Since 2008Supporting regulated industries
ISO/IEC 17025Accredited testing and calibration laboratories
Complete Project SupportFrom planning to final reporting
International ExperienceProjects delivered across multiple international markets
ABOUT LABMERIT
Integrated GxP and Technical Support
Founded in Serbia in 2008, Labmerit is a multidisciplinary GxP partner supporting pharmaceutical, biotechnology, healthcare and other regulated industries.
We provide integrated qualification, validation, testing and calibration services throughout the lifecycle of facilities, utilities, equipment and computerized systems. Our qualification and validation expertise is reinforced by the technical competence, measurement traceability and controlled processes of our ISO/IEC 17025 accredited testing and calibration laboratories.
From initial planning and risk assessment to test execution, evaluation of results and final reporting, we help clients establish and maintain compliant, reliable and efficient operations.
About LabmeritOUR SERVICES
Integrated Services for Regulated Environments
Technical and compliance support for facilities, utilities, equipment, processes and computerized systems.
Process and Cleaning Validation
Risk-based validation of manufacturing processes and cleaning procedures, from strategy and protocol development to execution support, evaluation and final reporting.
Process ValidationCleaning Validation
Computerized Systems Validation
Risk-based validation of GxP computerized systems, including EMS, BMS, SCADA, ERP, WMS, LMS/LIMS, QMS and cloud-based applications.
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.
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.
WHY LABMERIT
Why Clients Choose Labmerit
Regulatory Understanding
Our work is planned and documented in accordance with applicable regulatory requirements, recognized standards and current good practices.
Integrated Expertise
Qualification, validation, testing, calibration and computerized systems validation are coordinated within one multidisciplinary organization.
Risk-Based Approach
The scope and depth of our activities are defined according to system criticality, intended use and identified risks.
Clear and Traceable Documentation
Our protocols, records and reports provide transparent evidence of the activities performed, results obtained, deviations identified and conclusions reached.
INDUSTRIES
Industries We Support
Our services are adapted to the regulatory framework, technical requirements and operational risks of each industry and project.
01Pharmaceutical Manufacturing
02Biotechnology
03Healthcare and Hospitals
04Medical Devices
05Pharmaceutical Distribution and Logistics
06Laboratories and Research Institutions
07Food and Other Regulated Industries
OUR APPROACH
From Project Definition to Final Report
Define
We review the system, its intended use, applicable requirements and the client’s objectives.
Plan
We define scope, responsibilities, test methods, acceptance criteria and required documentation.
Execute
Our team performs the agreed activities using controlled procedures and suitable calibrated equipment.
Report
Results, deviations, assessments and conclusions are presented in clear and traceable final documentation.
ACCREDITATION
Accredited Testing and Calibration Laboratories
Labmerit operates ISO/IEC 17025-accredited testing laboratory 01-303 and calibration laboratory 02-071. Accreditation applies exclusively to the activities, methods and ranges defined in the current Scopes of Accreditation.
View Accreditation and ScopesTesting Laboratory
No. 01-303Calibration Laboratory
No. 02-071INTERNATIONAL EXPERIENCE
Supporting Projects Across International Markets
Labmerit supports projects across Europe and in the Kingdom of Saudi Arabia (KSA).
EuropeKingdom of Saudi Arabia (KSA)
OUR TEAM
Key Contacts
Meet the people responsible for the coordination, quality and technical delivery of Labmerit services.
DI
Dragan Ilić
Director and Head of Accredited Laboratories
DB
Darko Bobić
Deputy Director and Project Manager
SJ
Slavica Jovanović
Quality Assurance Manager
MS
Milutin Smiljanić
Head of Validation and Qualification Department
MB
Milica Blagojević
Deputy Head of Accredited Laboratories
IM
Igor Mandić
Computerized Systems Validation Expert
START A CONVERSATION
Planning a Qualification, Validation, Testing or Calibration Project?
Tell us about your facility, system, equipment or compliance requirement. Our team will review your needs and help define an appropriate scope of work.