Also -- based on Code of Federal regulations, product traceability has to be absolutely guaranteed. from a med device standpoint, we can trace all mfg data for a product given a lot/part number combination. That should be maintained and quickly determinable (in the event of a recall) and is a requirement of devices and I assume drugs. …
Also -- based on Code of Federal regulations, product traceability has to be absolutely guaranteed. from a med device standpoint, we can trace all mfg data for a product given a lot/part number combination. That should be maintained and quickly determinable (in the event of a recall) and is a requirement of devices and I assume drugs. Required traceability is not just mfg location, it's also specific equipment, specific employees that assembled it, inspections, testing results, etc. Basically the entire lot history record has to be available in the event of audit or need to analyze product quality signals to support a recall.
Also -- based on Code of Federal regulations, product traceability has to be absolutely guaranteed. from a med device standpoint, we can trace all mfg data for a product given a lot/part number combination. That should be maintained and quickly determinable (in the event of a recall) and is a requirement of devices and I assume drugs. Required traceability is not just mfg location, it's also specific equipment, specific employees that assembled it, inspections, testing results, etc. Basically the entire lot history record has to be available in the event of audit or need to analyze product quality signals to support a recall.
damned straight!