QUALITY ASSURANCE

In Avant Santé we as a team, aware of the great importance of the quality our services have, especially as a determining factor to establish the progress and overall reliability to contribute to the health care of people. This understanding has led us to adopt our vision and adopt Quality as the corporate value in Avant Santé.

Quality for us is not that our products and services meet our own specifications, means achieving the specifications and requirements of our customers nationally or internationally. It means quality in our dealings with volunteers and clients. Quality is therefore a collective responsibility of all and is not limited to an individual or division.

Our commitment to quality is an ongoing commitment to exceed the quality levels expected by our business partners in all that we carry out.

The Avant Santé team is strengthened with experience and understanding of technical standards and regulatory standards. We have well founded our understanding of standard operating processes, training systems, instrumentation and quality principles. We ensure adherence to customer requirements and applicable regulations such as COFEPRIS, FDA, ANVISA, MHRA and some others. We are committed to delivering services that comply with Good Clinical Practices (GCP). Good Laboratory Practice (GLP) and the International Conference on Harmonization (ICH).

Our commitment to continuous quality allows us to create a strong system of corrective and preventive actions (CAPA). Our quality team investigates deviations, discrepancies, incidents, etc., and works proactively to detect, correct and prevent actions in time and with accurate documentation. Our processes preventive maintenance and calibration programs are on par with the best in the industry.

The Quality Department is an independent entity with independent operations.

Pre-scheduled internal / external compliance audits are performed.

It has a solid base of Corrective and Preventive Actions (CAPA).

The best in the industry in calibration and preventive maintenance programs.

Extensive Change Control process for tracking and improving quality.

Rigorous control of the flow, distribution and archiving of documents.

Analysis of trends in Quality in all areas of continuous improvement.