Quality Assurance & Compliance
REVIVE is committed to provide operations in high quality standards
The project activities will be conducted efficiently and in accordance with international quality standards, best practices and ethical principles to ensure that the clients and regulatory authorities accept the best possible services and products are implemented.
Quality Management System (QMS)
A Quality Management System is followed to ensure that all operations and projects adhere to local and international quality regulatory requirements and guidelines e.g., Principles of Good Clinical Practice and ICH guidelines. This consists of components:
- Quality assurance with highly qualified personnel
- Detailed Standard Operating Procedures (SOPs) describing responsibilities and duties
- Regular audits
Quality Assurance Department
Quality Assurance (QA) department is an independent unit focuses on the continual improvement of Quality Management System to ensure the highest level of quality and efficiency at every step of clinical development.
The SOPs contain quality control mechanisms and Quality Management System requires that SOPs (either ours or yours, if requested) are followed to ensure Good Clinical Practice compliance.
The clients regularly conduct audits of well-structured Quality Management System. The QA team will conduct regular Internal Audits in all areas of our business to maintain reputation for quality and compliance.
In-house capabilities to perform:
- Site, Vendor, Systems | Process Audits
- Document review Audits (Protocol, Clinical Study Reports & essential Clinical Trial documents)
- GCP compliance review
- IRB | EC audits
- Drug accountability reviews
- Database audit
- Internal Audits for Area Specific SOP compliance
- All our QA systems are compliant with all applicable local & international regulations.