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Quality management

Scanelis analyses are performed within a strict quality assurance program according to ISO 17025 standards.

Monitoring and traceability of analyses
A Laboratory Information Management System (LIMS) is being installed at the Scanelis laboratory offering fully automated monitoring of samples from their registration to delivery of the results and invoicing.

Premises
The Scanelis’ laboratory has been designed to offer high safety & security and to ensure a strict forward workflow of samples.

Assay development and validation
All assays are developed in accordance with the European Pharmacopoeia recommendations (2.6.21) and NF U47-600-2 standards.

Analyses for quality control of biological products
A specific quality plan is set up in accordance with the European Pharmacopoeia recommendations and can be adapted to meet customers requirements and specifications.