Quality Assurance Services
Quality Assurance is the backbone of every successful clinical trial. At Genelife Clinical Research, our dedicated QA department ensures that all clinical operations, data management processes, and regulatory submissions adhere to the highest quality standards — making us a trusted CRO in India for sponsors who demand GCP excellence.
Our QA services protect your clinical program from the risks of non-compliance, data integrity failures, and regulatory inspection findings — ensuring every study we conduct or support is audit-ready at all times.
& Strategy
Inspection
Resolution
Improvement
GCP Audits
Genelife provides comprehensive GCP audit services — both for our own studies and as an independent QA partner for sponsor organizations.
Clinical Site Audits
Systematic on-site assessment of investigator sites against ICH-GCP, CDSCO, and sponsor-specific requirements — evaluating protocol adherence, source data verification, informed consent processes, and overall site quality.
Trial Master File (TMF) Audits
Comprehensive review of trial master file completeness, accuracy, and regulatory compliance — ensuring all essential documents are present, current, and correctly filed per ICH E6 (R2) requirements.
Laboratory & Vendor Audits
Assessment of central laboratories, bioanalytical facilities, and other vendors against applicable quality standards — including GLP compliance, chain of custody, and data integrity evaluation.
Sponsor / CRO Systems Audits
Evaluation of sponsor or CRO quality management systems, SOPs, training records, and operational processes — ensuring organizational readiness for regulatory inspections.
SOP Development & Review
Well-written, comprehensive Standard Operating Procedures are the foundation of a quality clinical research operation. Our SOP services ensure your organization has clear, compliant, and practical procedures covering all critical processes.
- SOP Gap Analysis — identifying missing or outdated SOPs against ICH-GCP, CDSCO, and regulatory requirements
- SOP Writing & Review — developing new SOPs or reviewing and updating existing ones for scientific accuracy, regulatory compliance, and operational practicality
- SOP Training Programs — designing and delivering SOP training for site staff, CRO teams, and sponsor personnel
- SOP Version Control — implementing document management systems ensuring SOPs are current, controlled, and accessible
Quality Management System (QMS)
QMS Design & Implementation
End-to-end design and implementation of Quality Management Systems for CROs, sponsors, and investigator sites — covering quality planning, quality control, quality assurance, and quality improvement processes.
Quality Metrics & KPI Monitoring
Development of quality dashboards, key performance indicators, and metrics tracking systems — enabling proactive identification of quality risks and real-time visibility into study quality status.
CAPA Management
Structured Corrective and Preventive Action (CAPA) management — root cause analysis, action planning, effectiveness verification, and closure — ensuring systematic resolution of quality findings.
GCP Training Programs
Comprehensive GCP training for investigators, site staff, monitors, and sponsor personnel — covering ICH-GCP E6 (R2), CDSCO regulations, and study-specific requirements.
Regulatory Inspection Readiness
Regulatory inspections by CDSCO, USFDA, EMA, or other agencies require thorough preparation. Genelife's inspection readiness services ensure your team and documentation are fully prepared to demonstrate compliance.
- Mock Inspections — simulated regulatory inspections identifying gaps before the real inspection
- Inspection Preparation Workshops — training site staff and sponsor teams on inspection conduct and expectations
- Document Readiness Review — ensuring all critical documents are complete, consistent, and readily retrievable
- Back Room Support — on-site QA support during actual regulatory inspections
- Post-Inspection Response — preparing responses to regulatory findings and implementing corrective actions
Data Integrity & Compliance
- 21 CFR Part 11 and Annex 11 compliance assessment for electronic systems
- Data integrity audits of EDC systems, CTMS, and laboratory data systems
- Audit trail review and computerized system validation oversight
- ALCOA+ principles implementation (Attributable, Legible, Contemporaneous, Original, Accurate)
Why QA Matters: A single regulatory finding can delay product approval, result in clinical hold, or require costly study repetition. Genelife's proactive Quality Assurance services protect your clinical investment and ensure your data stands up to the highest scrutiny from CDSCO, FDA, EMA, and other global regulatory agencies.