A quality management system implemented at every level of your study.
CellCarta has a comprehensive quality management system spanning all levels of our organization that complies with the applicable GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GCLP (Good Clinical Laboratory Practice), and ISO 13485 (Quality Management System Requirements for medical devices) requirements. Our QMS directs the work from assay design and validation through to study planning, conducting, monitoring, reporting, and archiving.
All activities are performed by qualified, trained personnel and recorded in approved controlled documents such as study work plans, Client Specific Procedures (CSPs), and study worksheets. Our QMS ensures every document is reviewed and approved before use for consistent, auditable execution across studies.
Assays are developed, qualified, and validated to meet customer needs and applicable regulatory requirements. Whether for an exploratory endpoint or a clinical trial assay with a companion diagnostic end goal, the appropriate compliance framework is applied from the start.
Reporting formats and methods are developed in close collaboration with sponsors to ensure test results are communicated clearly and meet the sponsor’s requirements. Structured, sponsor-aligned reports help reduce review cycles and facilitate regulatory submissions.
Quality Control (QC) is performed and documented throughout laboratory testing execution, with integrated QC checkpoints that protect data integrity implemented at every stage.
The Quality Assurance (QA) Unit conducts audits in accordance with GLP/GCP regulatory requirements, study plans, and applicable procedures. Our QA audits measure and monitor laboratory performance as well as identify opportunities for continuous improvement.
Proficiency Testing allows for the standardization of selected assays among laboratories, as required by CAP accreditation and CLIA certification. This program is a structured component of CellCarta’s quality management, ensuring that assay performance is consistent and reproducible across global sites.
All activities are performed by qualified, trained personnel and recorded in approved controlled documents such as study work plans, Client Specific Procedures (CSPs), and study worksheets. Our QMS ensures every document is reviewed and approved before use for consistent, auditable execution across studies.
Assays are developed, qualified, and validated to meet customer needs and applicable regulatory requirements. Whether for an exploratory endpoint or a clinical trial assay with a companion diagnostic end goal, the appropriate compliance framework is applied from the start.
Reporting formats and methods are developed in close collaboration with sponsors to ensure test results are communicated clearly and meet the sponsor’s requirements. Structured, sponsor-aligned reports help reduce review cycles and facilitate regulatory submissions.
Quality Control (QC) is performed and documented throughout laboratory testing execution, with integrated QC checkpoints that protect data integrity implemented at every stage.
The Quality Assurance (QA) Unit conducts audits in accordance with GLP/GCP regulatory requirements, study plans, and applicable procedures. Our QA audits measure and monitor laboratory performance as well as identify opportunities for continuous improvement.
Proficiency Testing allows for the standardization of selected assays among laboratories, as required by CAP accreditation and CLIA certification. This program is a structured component of CellCarta’s quality management, ensuring that assay performance is consistent and reproducible across global sites.
CellCarta operates eight facilities across North America, Europe, and Asia-Pacific. All CellCarta sites are ISO-certified and CAP/CLIA-accredited, as applicable to their activities. ISO 27001 accreditation, Information Security Management Systems, is also maintained across all sites.
Across our globally owned laboratories, CellCarta is united under one QMS. This ensures all processes, procedures, and electronic systems are standardized no matter which site processes your samples.
Every process, assay, and data deliverable governed by a single quality framework.
Quality at Every Level
Audit-Ready Documentation
GCP/GLP/GCLP Compliance
High-Integrity Data
Cross-Standardization
Explore our regulatory-ready clinical laboratory services, supported by CAP and CLIA accreditation across our global sites.
From prototype assay to IVD and CDx — development, validation, and submission support.
Discover CellCarta’s full list of accreditations across our eight global facilities.
A full range of services across immune monitoring, proteomics, genomics, and histopathology.
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CellCarta’s quality management program is implemented in accordance with GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GCLP (Good Clinical Laboratory Practice), and ISO 13485 (Quality Management System Requirements for medical devices). These frameworks guide our work from assay design and validation through study planning, conduct, monitoring, reporting, and archiving. The specific regulatory requirements applied to any given study depend on study type and the intended regulatory end point.
CellCarta’s overarching quality management system encompasses organization and facilities, safety and personnel, computer systems and equipment, sample management and chain of custody, assay and method qualification and validation, study planning, sample processing and data analysis, reporting, document control, and storage and retention of data. This scope means that every element of a sponsor’s study is governed by the same quality framework, reducing the operational risk that arises when quality oversight is limited to individual testing steps.
CellCarta’s Quality Assurance Unit conducts internal audits in accordance with GLP/GCP regulatory requirements, study plans, and applicable procedures. These audits measure and monitor laboratory performance and identify opportunities for improvement. All processes are documented in approved controlled documents — study work plans, SOPs, CSPs, and study worksheets — that are available for sponsor review and regulatory inspection.
CellCarta operates a structured complaints process for laboratory services. Complaints are followed up by the local project management team, ensuring that each concern is addressed by the team with direct knowledge of the study and site context. This process is a documented component of CellCarta’s Clinical Laboratory Services framework and operates within the broader laboratory quality management system, meaning complaint records are maintained, reviewed, and traceable in the same controlled document environment as study data and QA audit findings.
Yes. CellCarta’s clinical laboratories are accredited by the College of American Pathologists (CAP) and hold Clinical Laboratory Improvement Amendments (CLIA) certificates of accreditation. CAP and CLIA dual accreditation is maintained at the following sites: Antwerp (Belgium), Lake Forest CA (USA), Montreal (Canada), and Naperville IL (USA). CAP accreditation is also held at Gosselies (Belgium) and Jining (China) sites. These credentials are subject to regular proficiency testing requirements, which CellCarta fulfils through its proficiency testing program to standardize selected assays across laboratories.
