Medical Device Corrective Actions (CAPA) Software Systems

21 CFR Part 820 QSR Compliant Medical Device Corrective Actions (CAPA) Software Systems

MasterControl's medical device CAPA software system is designed for the overall effort to investigate and correct quality issues to prevent recurrence. CAPA is an important principle of the Quality System Regulation (QSR) outlined in 21 CFR Part 820. Specifically, Section 820.100 requires manufacturers to establish and maintain procedures for implementing CAPA that would cover products, processes, and the quality system.

Medical device corrective action software is equally important for medical device manufacturers that are ISO-certified. Both ISO 13485 and ISO 9000 require corrective actions and remedial processes to correct nonconformance and prevent their recurrence.

Simplify CAPA in 7 Steps
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