Comprehensive Quality, Compliance & Validation Support Across the Product Lifecycle

At CLINZTECH, we deliver end-to-end GxP (Good Practices) Audit and Consulting Services, empowering pharmaceutical, biotechnology, medical device, and life sciences organizations to maintain global regulatory compliance, mitigate risk, and enhance operational quality. Our services span from assessment and remediation to validation and automation, aligning your systems with international standards including FDA, EMA, MHRA, CDSCO, WHO, ICH, and PIC/S.

GxP Audit Services

Our GxP audit services are tailored to assess, establish, and strengthen quality systems across the enterprise. Whether you’re a start-up, CDMO, or a global player, CLINZTECH ensures your operations are audit-ready.

Core GxP Services Include:

• ✅ GxP Compliance Assessment & Process Establishment
  Evaluate and establish quality systems aligned with current regulatory expectations across GMP, GLP, GCP, and GAMP domains.
• ✅ Routine & Targeted Audits
  Conduct function-specific or molecule-specific audits to assess system robustness, compliance adherence, and data integrity.
• ✅ Due Diligence Audits
  Comprehensive auditing of customer vendors/suppliers to assess compliance, capability, and risk.
• ✅ Inspection Readiness Evaluation
  Assess organizational preparedness for regulatory inspections; identify and close compliance gaps.
• ✅ Root Cause Analysis (RCA) & CAPA Management
  Expert support for responding to regulatory audit findings, including effective CAPA development and efficiency evaluation.
• ✅ Audit Report Compilation & Submission
  Professional documentation of findings with risk-based recommendations, timelines, and audit summaries.

Types of GxP Audits Conducted

• GMP (Good Manufacturing Practice) Audits
• cGMP Compliance Assessments
• GMP Gap Analysis & Remediation Planning
• GAMP (Good Automated Manufacturing Practice) Audits
• GLP (Good Laboratory Practice) Audits
• GCP (Good Clinical Practice) Audits
• Audit Trail Adequacy Assessments
• Response Management to Regulatory Audit Reports

QMS Remediation & SOP Services

We help build and enhance your Quality Management System (QMS) through structured remediation efforts.

Key Offerings:

• 📄 SOP Gap Analysis & Remediation
• ✍️ SOP Preparation and Optimization
• 🎓 GxP Training Programs and Competency Building
• ✅ Systematic Documentation and Change Control Implementation

Validation Services

Our validation services cover both new and legacy systems to ensure they meet global regulatory expectations.

1. Computer System Validation (CSV)

• Progressive validation based on FDA’s 21 CFR Part 11, Annex 11, and GAMP 5
• Structured validation lifecycle with predefined quality gates
• Secure, compliant, and fit-for-purpose system qualification
• Complete documentation including Validation Plans, Protocols, Traceability Matrix, and Validation Certificates

2. Retro (Retrospective) Validation

• Analysis and remediation for existing or legacy systems
• Gap identification in existing documentation
• Retrospective validation execution and certification issuance

Specialized Assessments & Compliance Services

• ERES (Electronic Records & Electronic Signatures) Assessment
• Audit Trail Integrity and Review
• Business Continuity (BCM) & Disaster Recovery (DR) Adequacy
• Manufacturing Facility Audits
• Vendor Qualification and Audits

GxP Compliance Consulting & Automation Solutions

CLINZTECH also provides technology-enabled solutions to streamline GxP operations, automate workflows, and reduce manual errors.

CAPA Systems

• Root Cause Identification
• Corrective and Preventive Action Plans
• Workflow-enabled CAPA tracking and documentation

QMS Solutions

• SOP Automation
• Integrated GxP Workflow
• Digital approvals and signature-free validation

Training Management Systems

• Automated assignment of role-based training
• Electronic tracking of training completion
• GxP-compliant documentation and audit readiness

Helpdesk/Service Ticketing Systems

• GxP-aligned ticketing systems for issue resolution
• Seamless integration with quality and validation systems
• Real-time tracking and closure compliance

Why CLINZTECH?

• Global Regulatory Expertise across FDA, EMA, MHRA, CDSCO, TGA, ANVISA, PMDA, and WHO
• Cross-functional Specialists including auditors, QA experts, data integrity leads, and CSV professionals
• Advanced Tools and Automation to digitize compliance systems
• Risk-Based, Audit-Proof Approach aligned with ICH Q9/Q10 principles
• End-to-End Support from assessment to certification and regulatory submission

Partner with CLINZTECH to ensure your systems are validated, your operations are compliant, and your team is always inspection-ready.