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One of the pillars of our philosophy as a company is to focus our efforts on the quality of our services:
- Quality in terms of control and traceability at every step of each study, from the precise definition of the customer's need, the control and registration of every sample before testing, to the results' delivery in strict respect of the study plan requirements or design. The satisfaction of our customers and the continuous improvement of the quality are our major priorities.
- Quality in terms of regulatory compliance, including the ISO 9001:2008 and the compliance Good Clinical Laboratory Practices (GCLP).
Customer’s Request qualification
We have implemented an internal process to qualify the customer’s request: from basic questions - how many enrolled patients? How many samples to test? How many time points? How many replicates? What are the deadlines? Should the study be run in GLP conditions? etc… - to more complex questions covering study design and methodology optimization, level of validation expected, type of data analysis, etc.
This process helps us and our customers share a common and clear vision of the study and improve the quality of the final results.
Our Quality Control procedures are driven and piloted by a dedicated team, independent of the testing staff, in order to ensure the highest standards of quality and accuracy.
Process Control during sample reception:
- Checking: identification, specifications (type of sample, volume, visual inspection
- Sample registration: identity, date of reception, sample condition upon arrival, all deviations are reported.
Facilities and procedure for samples traceability: data base, equipment inventory
Monitor and control of storage conditions: maintain integrity and accessibility of samples
In process Control
- Our SOPs are regularly reviewed
- Trained and qualified staff
- Full traceability and record of analyses
- Internal and external in-process control
- Qualification of reagents: batch comparison, stability studies when required, dedicated storage area
- Controlled pressure and temperature lab space
- Equipment qualification (IQ, OQ, PQ) and periodic maintenance program
All output data are systematically approved by a scientific manager.
Complete check of analytical results includes conformity on:
- Documentation and traceability record
- Acceptance criteria (internal, negative, positive controls,…)
- Samples, equipment, and reagents used
Analysis Certificate Delivery.