Quality Control and Assurance
Quality Control and Assurance
globeELIXIR conduct projects and activities efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that our clients and regulatory authorities are provided the best possible services and products.
To comply with international quality standards, we have designed a Quality Management System. This system ensures that all operations and projects adhere to local and international regulatory requirements of guidelines, and Principles of Good Clinical Practice and ICH guidelines. This consists of the following components:
- Quality assurance
- Well-structured organization with highly qualified personnel
- Detailed Standard Operating Procedures describing responsibilities and duties
- Regular audits
- System improvement and consultancy
Our Quality Assurance department is an independent unit reporting to the higher management. The department’s main focus is the continual improvement of globeELIXIR.
Our SOPs contain quality control mechanisms and our Quality Management System requires that SOPs are followed to ensure Good Clinical Practice compliance.
Our clients regularly conduct audits of our well-structured Quality Management System. We have been successfully approved in all external client audits. Our QA team conducts regular Internal Audits in all areas of our business to maintain our excellent reputation for quality and compliance.
Involved at every step of clinical development, globeELIXIR QA staff ensures that your projects receive the highest level of quality and efficiency. System improvement and consultancy is given on a continuous basis to all our personnel and to clients as requested. Our QA personnel maintain an optimal level of knowledge through ongoing continuing education and regular participation at QA and other conferences.
- Site Audits
- Systems | Process Audits
- Vendor Audits
- Document Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)
- GCP compliance review
- IRB | EC audits
- On-site investigator audits
- Drug accountability reviews
- Database audit
- Study document reviews
- Internal Audits for Area Specific SOP compliance
- All our QA systems are compliant with all applicable local & international regulations.