Quality ICHE6R2 ISO13495v2016 Delta Consultants

English version

Quality Assurance

Zero tolerance

Because inaccuracy and uncertainty cannot be tolerated at any time during project or study, DELTA CONSULTANTS employs rigorous quality and control criteria at all steps.

Delta Consultants is compliant with ICH E6 GCP R2 and ISO 13485:2016

Guarantees

Monitoring of regulations and procedures
DELTA CONSULTANTS’ evolving procedures respect the latest recommendations. Procedures, operating methods and models are updated routinely every 2 years, or earlier if required by international recommendations. Monitoring of regulations is ensured to integrate any evolutions. As such, DELTA CONSULTANTS’ team receives continuous training related to new procedures and regulations.

DELTA CONSULTANTS’ procedures guarantee a high standard, with traceability and internal and external quality controls in all areas at all steps, each document being validated prior to transmission to the Customer.

Security
Data Backups are performed automatically each day on an external disk stored in a safe on Company premises, in a protected and air-conditioned environment. A backup is also outsourced and stored in a safe at a different geographical location. The server, premises and archives all have restricted access.

Confidentiality
DELTA CONSULTANTS is committed to strict confidentiality, respecting Customer and data anonymity.