Quality Assurance (QA) Services at CLINZTECH

At CLINZTECH, we recognize that quality is the foundation of trust, safety, and regulatory compliance. Our in-house Quality Assurance (QA) team provides comprehensive and customizable auditing and quality system support services to ensure adherence to international standards across Clinical Trials, Information Technology, Banking and Finance, Pharmaceuticals, and Life Sciences.

Whether you need project-specific audits, regulatory inspection readiness, or full Quality Management System (QMS) development, CLINZTECH offers standalone and integrated QA solutions tailored to your organization’s needs—delivered by a globally distributed team of experienced auditors.

Scope of QA Services

1. Clinical Quality Assurance (CQA)

• GCP Audits (Phases I–IV): Verification of compliance with ICH-GCP and sponsor SOPs across investigational sites, CROs, and vendors.
• Site Audits: Review of patient consent, source data, CRF completion, and adherence to protocol.
• Vendor Audits: Assessment of CROs, laboratories, and third-party data management vendors.
• Trial Master File (TMF) Audits: In-depth review of essential documents for completeness and compliance.

2. IT and Computer Systems QA

• Computer System Validation (CSV): Audits of system life cycle, data integrity, and Part 11 compliance.
• Software Quality Assurance: Evaluation of SDLC processes and risk-based testing frameworks.
• IT Infrastructure Audits: Security, data privacy, and regulatory compliance of IT assets.
• Database and Statistical Outputs Audits: Verification of statistical tables, listings, and figures (TLFs) for accuracy and reproducibility.

3. Pharmaceutical and Laboratory QA

• GLP Audits: Assessment of preclinical lab facilities and processes per OECD GLP and FDA guidelines.
• GMP Audits: Audits of manufacturing, quality control, packaging, and storage practices.
• Clinical Laboratory Audits: Evaluation of lab certifications, SOPs, equipment calibration, and test result integrity.

Global Regulatory Compliance Support

• Pre-FDA and Regulatory Inspection Preparation: Mock inspections, CAPA (Corrective and Preventive Action) management, and documentation readiness.
• Inspection Readiness Training: Custom training modules to prepare staff and sites for inspections by regulatory bodies such as the FDA, EMA, MHRA, PMDA, and WHO.
• Deviation and Non-Compliance Management: Root cause analysis and action plans to remediate findings.

Quality Systems Development and Maintenance

• QMS Development and Review: Establishment of SOPs, work instructions, quality manuals, and document control systems.
• Process Improvement Initiatives: Lean and Six Sigma methodologies to streamline operations and reduce error rates.
• Risk-Based QA Planning: Prioritizing audit areas based on product risk and business impact.

Global Coverage with Local Expertise

CLINZTECH’s QA professionals are strategically located across North America, Europe, Asia-Pacific, Latin America, and Japan, enabling us to offer:

• Personalized QA solutions tailored to regional regulatory expectations
• Cost-effective and culturally aware service delivery
• On-site or remote audits with flexible scheduling

Why Choose CLINZTECH for QA Services?

• ✅ Cross-Industry Expertise: Extensive experience in Clinical Trials, Pharma, IT, and Finance sectors
• ✅ Qualified Auditors: Certified GCP/GMP/GLP auditors with domain-specific knowledge
• ✅ Regulatory Readiness: Proven support for FDA, EMA, MHRA, PMDA, and other global inspections
• ✅ Global Reach, Local Insight: Regional experts delivering personalized, on-the-ground service
• ✅ Audit-Ready Systems: Robust documentation and evidence-driven approach to QA
• ✅ Independent & Confidential: We operate with full discretion and transparency

Whether you’re conducting a multinational clinical trial, launching a new software platform, or enhancing your quality systems, CLINZTECH’s Quality Assurance team is your dedicated partner for compliance, consistency, and confidence at every step.