Validation Ensures Accurate Traceability
A major part of the manufacturing process for this major medical
device manufacturer based in the Twin Cities is the packaging of the
devices that are delivered to hospitals for use. If they put the device
into the wrong box, they could be charged substantial fines and have
traceability issues making accuracy very important. It is imperative
that the same unique product information is on the product and
paperwork, as well as internal and external packaging in the event of
recalls. As the company grew, they discovered they needed a better
system to ensure packaging was done correctly and accurately.
Coridian’s software application team developed a validation program
for this manufacturer that cross checks different items for specific
information. The program validates that the work order, product,
pouch label and the box label all match. It looks for the expiration
data, lot number and reference number, and if any of these fields
don’t match the work order, an error is displayed and it must be
corrected before starting the process over again. The program also
stores data to confirm that the validation has been done and the time
and date it was completed.
Coridian not only developed this program for the company, they
also helped design a custom set label. This set label contains various
labels that are used on pouches, paperwork and boxes. This set label
travels with the product from the start to end of the process and
labels are taken from the set as required. Having one label set with all
the needed labels as one piece helps ensure the unique serial number
doesn’t get applied to another product.
With this new validation program, the company can be sure
they are sending the correct part to the hospital. This fulfills
their FDA requirements, and ensures the hospitals have the
correct devices, which is very important to patient safety.
The company’s increased efficiencies protect their brand and
add value to their organization.
Download Case Study PDF