Validation of a laboratory process in a contract research organization

Validierung eines Laborprozesses CRO - QFINITY

A manufacturer of high-performance ceramics for dentists and dental technicians planned to introduce a new ERP system and needed to take the new system’s 21 CFR Part 11 capability into account. QFINITY∞ also ran a workshop to work out the recommendations to consider for Part 11 in the new system.

Audit of the Quality Management Processes of a small/midsize CROTitelbild zum Beitrag: Auditierung des Studienprozesses eines universitären InstitutsTitelbild zum Beitrag: Auditierung der Datenmanagement Prozesse (für klinische Prüfungen)Data Management Audit of processes and computerized systems at an academic spinoff...