Our QA director carries out external and internal audits.
Quality Control of:
- general management activities
- fulfillment of contract requirements
- corrective / preventive actions
ADDS fulfills ISO 9001 certification requirements.
Today, our quality management system is well-implemented. We have set up a constant update of our standards that allows us to reinforce and upgrade our quality management.
Our quality management system:
- Internal auditing:
- planned in the quality system plan and performed during the year
- audits include all activities such as monitoring, project management, data management, statistics, Pharmacovigilance and Risk Management
- Archive: all types of documents are filed and archived according to national laws, guidelines and ADDS procedures
- Document control: quality procedures, work procedures administration and computer procedures revised and corrected at least once a year.
- Training:
- several training profiles - methods, procedures, quality and trainings before and during project
- constant internal training of ADDS teams
Our activities:
- Audit of investigator centres
- Audit of suppliers and services providers
- Preparation and assistance to inspections
- Set up of quality plans
- SOP development
- Routine quality controls