Biocartis is an innovative molecular diagnostics company committed to revolutionizing molecular testing. In their Mechelen site, they are assembling PCR tests on two manufacturing lines. All the systems and types of equipment used on these two lines require a periodic review according to the Medical Devices Regulation. ALTEN accompanied them with the Periodic System Quality Review.

ALTEN ACTIVITIES

• Verify that the data were correctly collected.
• Plot yield data and evaluate the trend.
• Evaluate all quality events related to the system (Deviation, CAPA, and change control).
• Analyze all maintenance and calibration data.
• Verify the computer system validation.
• Verify the Q&V status.

STANDARDS AND TOOLS

• Medical Device Regulation
• ISO 13485
• QMS Software

ALTEN ADDED VALUE ▸ Easy communication -> ALTEN SPOC and Client SPOC

▸ Reliability at a minimum cost

▸ Flexibility on the workload

▸ Executed by bio-engineers

▸C oached by a senior consultant