Medical devices
Medical device lots: the history while the lot is still open
A device lot is often reconstructed after the units are packed. Components, checks, and who did the work are assembled when the lot is already closed.
A missing check found then is an explanation. The same gap during the lot is still something the floor can hold.
What the open lot has to show
- Component lots issued before the device lot is closed.
- Checks on the open lot, not in a stack filled in later.
- The finished lot tied to the units and the shipment.
That is the same kind of gap as seeing the work while it is still open and quoting from a current cost.
The week the record is late
A component lot needs a list of device lots. The list is a search through travelers. Some of those units have already left.
MFGMAX Pharma keeps materials, the running record, checks, and cost together. This does not replace a device quality system. MFGMAX Pharma holds that record. Accounting can stay where it is. Other systems can connect. What moves, and when, is shown before you commit. This does not replace your quality system, a validation, or an FDA approval.
Mark the week on Problems and Solutions, or read how integrations stay with the platform instead of replacing it.
Questions
What should stay on the open lot?
Component lots issued before the device lot is closed. Checks on the open lot, not in a stack filled in later. The finished lot tied to the units and the shipment.
When should the lot be compared with the quote?
While it is still open. A count after invoicing explains a loss. It does not give the material or the hours back.
What does MFGMAX connect this to?
MFGMAX Pharma keeps materials, the running record, checks, and cost together. This does not replace a device quality system. This does not replace your quality system, a validation, or an FDA approval.