Quality management services (GLP / ISO) covering the entire process, from system implementation to auditing, ensuring compliance with the OECD Principles of Good Laboratory Practice (GLP) and the requirements of ISO 17025
Provision of QAU outsourcing services, including inspections of study plans, experimental phases, raw data and final reports, verifying data accuracy, integrity and compliance with applicable GLP and regulatory requirements
Comprehensive quality management services (GLP / ISO) from implementation to audit
Inspections conducted in accordance with GLP principles and ISO 17025, covering studies, processes and facilities
Design and implementation of complete GLP and ISO systems, tailored to the specific needs of the organization
Quality assurance program management, SOP development, risk analysis and data integrity (ALCOA++)
Personnel training on GLP principles, ISO standards (ISO 17025 / ISO 15189) and related regulations
Inspections of studies, processes and facilities are performed in line with Good Laboratory Practice (GLP) principles. They cover the study protocol, experimental / critical phases, raw data and final report, ensuring that every stage is properly conducted and documented according to approved protocols and GLP standards
Identify, evaluate and control risks that may affect the quality of the studies.
Data integrity ensuring that information is accurate, complete and protected over time
Validation (CSV) through DQ, IQ, OQ, and PQ stages, ensuring proper design, installation, operation, and performance
Writing and reviewing SOPs and templates. Management of the Quality Assurance Program and preparation of inspection reports
GLP services, audits, training, and quality management for laboratories. Compliance with OECD GLP, FDA, EPA and ISO 17025 standards, applying ALCOA++ principles to ensure traceability, regulatory compliance and data quality
Our approach is based on a rigorous risk analysis to design practical and customized solutions. This allows us to optimize your processes and ensure quality and regulatory compliance tailored to the specific needs of your laboratory.
We have extensive experience in applying quality principles to research, including support for multi-site studies, the management and validation of computerized systems and the management of test systems.
We conduct inspections in accordance with the Quality Assurance program established within each organization. Our specialized support covers complex areas such as field studies and studies involving biological systems (including microorganisms), ensuring the reliability and accuracy of the data generated
