Quality

Assured Quality. Accredited Excellence. Regulatory Compliance.

City Imaging and Clinical Labs is committed to delivering excellence in clinical diagnostics, central laboratory services, and core imaging solutions. This commitment is demonstrated through a strong quality framework, adherence to applicable accreditation, regulatory requirements, and continuous monitoring of operational standards across all service areas.

With scientific expertise, efficient project management, advanced technologies, skilled leadership, and regulatory acumen, CIRI seamlessly manages clinical trials ranging from small-scale academic studies to large, complex, regulatory submission trials.

Quality Management System (QMS)

As an integrated diagnostic and imaging service provider, City Imaging and Clinical Labs operates under a well-defined Quality Management System that ensures consistency, reliability, and compliance. The key elements of the QMS include:

Qualified and Competent Personnel

All staff are appropriately qualified and undergo structured training programs aligned with applicable regulatory and quality standards, including GCP, GCLP and ISO requirements relevant to both laboratory and imaging services.

Equipment Qualification and Management

A comprehensive and robust equipment lifecycle management system is implemented, including selection, installation, and qualification (IQ/OQ/PQ) of all laboratory and imaging equipment prior to routine use.

Calibration and Preventive Maintenance

All equipment is calibrated and maintained as per established guidelines and applicable accreditation requirements. A centralised equipment inventory is maintained, capturing details from procurement to decommissioning.

Document and SOP Control System

A robust document control framework is in place, supported by an extensive repository of approved Standard Operating Procedures (SOPs) governing laboratory processes, imaging operations, quality systems, and support functions.

Internal Quality Control (IQC) and External Quality Assurance (EQAS)

Established Internal Quality Control (IQC) procedures are routinely performed to monitor the accuracy and precision of test results. The laboratory also participates in External Quality Assurance Schemes (EQAS)/proficiency testing programs to benchmark performance, ensure inter-laboratory comparability, and support continuous quality improvement.

Data Integrity and Archival Systems

Secure data management practices are implemented, including validated archival systems and qualified third-party service providers, ensuring data integrity, traceability, and long-term accessibility.

Biomedical Waste Management

Biomedical waste is managed in compliance with applicable regulatory requirements, including the Biomedical Waste Management Rules, 2016, ensuring safe handling, segregation, and disposal.

Sample Logistics Management

Approved and qualified logistics partners are engaged for the safe transport of clinical samples ensuring proper handling, environmental control, traceability, and integrity throughout the transfer process.

Internal Audits

Internal audits are conducted by trained in-house Corporate Quality Assurance personnel at defined intervals. Audit activities are planned and executed at predefined stages of each study. These audits assess compliance with approved protocols, SOPs, and applicable standards such as GCLP, GCP and ISO 15189:2022. Audit findings are documented, and corrective and preventive actions (CAPA) are implemented and tracked for effectiveness.

Pre-initiation
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Initiation
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In-process
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Study Data Audits
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End of Study
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Study Closure

External Audits

The laboratory routinely undergoes audits by sponsors, regulatory authorities, and independent organisations. In its capacity as a central laboratory, City Imaging and Clinical Labs has been subject to and successfully completed over 10 national and international audits associated with clinical trials and research studies. These external assessments evaluate the laboratory’s readiness, compliance, and capability to support clinical studies and diagnostic services. Successful participation in such audits reflects the organisation’s commitment to maintaining high-quality standards and regulatory compliance.

NABL External Regulatory Audits
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Vendor - Sponsor Audits
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Vendor - CRO Audits

Accreditations & Certifications

City Imaging and Clinical Labs operates in accordance with internationally recognized quality and regulatory standards. Our laboratory and imaging services are aligned with applicable accreditation requirements to ensure accuracy, reliability, and global acceptability of data.

We adhere to standards including:

  • ISO 15189:2022 for medical laboratories
  • Good Clinical Practice (GCP)
  • Good Clinical Laboratory Practice (GCLP)

Our systems, processes, and personnel are continuously evaluated to maintain compliance with these frameworks, ensuring that all clinical and imaging data generated is fit for regulatory submission and clinical decision-making.

Proven Audit Excellence

City Imaging and Clinical Labs has a strong track record of successfully undergoing multiple national and international audits conducted by sponsors, CROs, and regulatory authorities.

As a trusted central laboratory partner, we have:

  • Successfully completed 10+ external audits for clinical trials and research studies
  • Demonstrated consistent compliance with study protocols, SOPs, and regulatory standards
  • Established robust Corrective and Preventive Action (CAPA) systems to address audit findings effectively

Our audit readiness and transparent processes reflect our commitment to maintaining the highest levels of quality, compliance, and operational integrity.

Standardisation & Process Excellence

Standardisation is at the core of our operations, ensuring consistency and reproducibility across all laboratory and imaging activities.

Our approach includes:

  • Implementation of validated and controlled Standard Operating Procedures (SOPs)
  • Use of qualified equipment with IQ/OQ/PQ processes
  • Routine Internal Quality Control (IQC) and participation in External Quality Assurance Schemes (EQAS)
  • Centralised data management systems ensuring traceability and integrity

Through continuous monitoring and process optimisation, we ensure that every sample, image, and data point meets predefined quality benchmarks and regulatory expectations.