calibration curve obtained automatically through Watson LIMS software

Quality assurance

QA unit assignment

At atlanbio, Quality is everyone priority. The quality is maintained through:

 

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:

 

The quality assurance manager checking data with a study managerThe quality assurance manager checking a Mass Spectrometry systemThe quality assurance assistant checking the reagents used in a GLP study

 

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:

 

Atlanbio is GLP compliant Grade A status since its debut in 2006 for ANSM (see ANSM statement) and by 2013 for ANSES (see ANSES statement).

 

These controls allow a Mutual Recognition between different countries to support worldwide registrations for our clients.

 

Consequently, studies are performed to meet international guidelines:

News

Arrival of a new collaborator

Atlanbio is pleased to welcome Dr. Jordane BIARC to our every expanding organization in September 2017. Read more.

2017 European Bioanalysis Forum in Lisbon

Atlanbio’s Dr. Xavier Bernard, Study Manager (Immunochemistry) will be attending the 2017 European Bioanalysis Forum (EBF) in Lisbon, Portugal June 20-22.  Read more.

WRIB 2017 in Los Angeles, CA

Our team will be pleased meet you at the WRIB annual meeting in Los Angeles, CA, April 3-7, 2017. We invite you to visit CiToxLAB and Atlanbio teams at Booth # 39 to hear some of our scientific updates and to discuss your bioanalytical needs. Read more.

Arrival of two new collaborators

Atlanbio is pleased to introduce two new collaborators who will join our expanding organization in February 2017. Read more.