Quality Assurance / Auditing
Clinart is ISO 9001: 2008 Certified
Clinart provides Quality Assurance services to support clients throughout the clinical research and development process. At ClinArt, dedication to quality is our commitment. Our global Quality Assurance (QA) team has the clinical and technical expertise to ensure that the appropriate quality systems are in place for our client’s clinical study.
In addition to providing routine internal quality assurance support, Clinart’s QA team provides auditing services to its clients.
Auditing Services include:
- Pre-Regulatory Inspection GCP Audits/Inspection Readiness
- Clinical and Specialty Vendor & Service Provider Audits/Assessments
- Clinical Investigator Site Audits
- IRB Audits
- Trial Master File Audits
- Validation/21 CFR Part 11 Compliance Audits
- Standard Operating Procedure (SOP) Evaluations
- Quality Systems Audits
We will consistently provide services that meet or exceed the requirements and expectations of our clients. We will actively pursure ever improving ” Quality” to achieve the client satisfaction through “Continual improving process” that enables each employee to do their job right first time and every time.
Our quality statament indicates our commitment and focuses on what is important to us as an oraganization. Our qualtiy policy statement acts as a compass in providing the direction and a framework for estabilishing key corporate level performance measures and related improvement objectives.