CLIN-Integrity
CLIN-Integrity: QA as a Service
“Integrity Is Our Foundation. Quality Is Our Focus.”
Clinitude’s QA services ensure your trials meet the highest ICH-GCP & ISO14155 standards and are fully inspection-ready. We help you build, review, and maintain robust quality systems while supporting your team with practical, risk-based solutions.
Our Expertise
Quality Management System (QMS)
- Set up or optimize QMS aligned with ICH-GCP & ISO14155 standards and your organization’s needs
- Develop Quality Policies, Manuals, SOPs, and key processes (CAPA, training, audits, etc.)
- Support digital transformation from paper-based to electronic QMS, including vendor selection, data migration, process digitization, and eQMS validation (21 CFR Part 11)
SOP Development & Process Optimization
- Create and update SOPs aligned with current regulations and best practices.
CAPA Management (Corrective and Preventive Actions)
- Guide organizations in root cause analysis, CAPA development, and implementation to address quality issues proactively and prevent recurrence.
Procedural Compliance Assessments and Risk Management
- Conduct thorough assessments of your internal processes to ensure compliance with ICH-GCP & ISO14155 standards, EMA, FDA, and other global regulatory requirements and to identify potential gaps and areas for improvement.
- Risk assessments and mitigation strategies for clinical trials
ICH-GCP & ISO14155 Audits
- Site, CRO, vendor, TMF, and system audits.
- For-cause audits based on compliance concerns.
ICH-GCP & ISO14155 Training
- Tailored ICH-GCP & ISO14155 standards training programs and refresher courses
- Custom materials: presentations, manuals, and e-learning modules