QA unit assignment
At atlanbio, Quality is everyone priority. The quality is maintained through:
- Methodical internal Quality Controls
- A strict standard operating procedure obedience
- A thorough Quality Assurance program
Atlanbio offers, in fully controlled GLP compliant laboratories, a comprehensive range of bioanalytical services for both Chromatography and Immunochemistry. The independent Quality Assurance unit of atlanbio relies on a strong expertise and a long-standing experience in the bioanalytical field: LC-MS/MS, Immunoassays and Immunogenicity testing.
The independent Quality Assurance unit of atlanbio has a strong knowledge of both European (EMA) and American (FDA) GLP and GCP regulations, including software validation and 21 CFR Part 11 Compliance (FDA). All Computerized systems are validated and 21 CFR Part 11 compliant.
The QA audit program includes:
- Study-based audits
- Facility-based audits
- Process-based audits
The QA unit has review access to all data and database systems and routinely uses chromatography and immunochemistry data systems, Nugenesis and Watson LIMS as audit tools. QA provides regular updates to management with on-going corrective and preventive actions, deviations and investigations. A Quality metrics program is in place.
QA unit input
A priority for the QA unit is to stay current on the evolving industry standards and on GLP and GCP regulation trends through participating in Bioanalysis conferences.
Atlanbio is a SOFAQ active member (French society of Quality Assurance).
QA unit provides regulatory updates to the management thorough staff training in collaboration with Qualilab consultants. Consequently, the QA unit is a major player for the employee training program. Should you wish to audit our facility, the QA unit is dedicated to provide you with all necessary assistance to prepare and conduct the audit.
Routine inspection programs from authorities
The QA unit is also in charge of the coordination of authorities inspections. The Quality Assurance unit is routinely inspected for GLP compliance by:
- The French Human Agency (ANSM) for human drug development
- The French Veterinary Agency (ANSES) for animal drug development
These controls allow a Mutual Recognition between different countries to support worldwide registrations for our clients.
Consequently, studies are performed to meet international guidelines:
- ANVISA - Brazilian Health Surveillance Agency
- EMA – European Medecines Agency
- FDA – US Food and Drug Administration
- MHLW / NIHS - Japanese Ministry of Health, Labor, and Welfare / National Institute of Health Sciences