Hello,
I've recently started at a medical device company in RA and the FDA came in around the same time. During the inspection, an inspector claimed that despite an adequate IQ/OQ/PQ for a new CNC machine (that did not specifically treat the internal software as a separate entity), our company should have validated the internal software separately.
The parts from the CNC machine are also 100% inspected, so between the formal qualification and 100% inspection, my first impression is that asking for a separate qualification for OTS software is overkill.
Is separate OTS software qualification typically required by the FDA? In my prior FDA inspections, I've never heard this claim.
Thanks in advance.
I've recently started at a medical device company in RA and the FDA came in around the same time. During the inspection, an inspector claimed that despite an adequate IQ/OQ/PQ for a new CNC machine (that did not specifically treat the internal software as a separate entity), our company should have validated the internal software separately.
The parts from the CNC machine are also 100% inspected, so between the formal qualification and 100% inspection, my first impression is that asking for a separate qualification for OTS software is overkill.
Is separate OTS software qualification typically required by the FDA? In my prior FDA inspections, I've never heard this claim.
Thanks in advance.