SEVERAL YEARS BACK, IRVING, CALIF.-BASED ASPEN
Medical Products, a maker of upper and lower spinal
orthotics, faced a labeling challenge. The company had
expanded its distribution in international markets and was
anticipating further growth overseas. But it was clear that it
would need to re-evaluate some aspects of its operations to
ensure they could support that growth.
One of those was its product labeling process. Aspen’s
existing procedure was heavily reliant on manual data
entry, which was both slow
and prone to error. The
company needed something
faster and more automated—basically, a system that
could better manage labels,
not just design and print
them.
As for what it wanted in a
new system, Aspen Medical
had a number of items on its
list. For instance, it wanted
a standalone system that would integrate with its existing
enterprise resource planning (ERP) software. It also wanted
a solution that could improve its ability to meet the vast
and ever-changing medical device manufacturer labeling
regulations. And it was looking for something that could
scale up as the company grew.
For help selecting the right system, Aspen turned to
supply chain automation specialist VantageID. VantageID,
in turn, teamed up with Aspen’s existing labeling-system
provider, Teklynx International, to find the right enterprise
label-management software for the client’s needs.
The solution the partners eventually chose is Teklynx
Central CFR, a browser-based integrated label-management
system that combines label design, printing, and tracking
capabilities into a single regulatory solution. As far as
Aspen’s requirements were concerned, the product checked
all the boxes: It could be integrated with Aspen’s ERP as
well as any ERP system the company might transition to in
the future. It’s specifically designed to meet regulatory stan-
dards, such as the Food and Drug Administration’s (FDA)
standard 21 CFR Part 11. And perhaps most importantly of
all, the system replaced the time-consuming manual label
data-entry process with bar-code scanning.
GOING GLOBAL
During the implementation process, Teklynx worked closely with Aspen to transition the medical device company’s
label templates from its old Teklynx Label Matrix system
to the new Central CFR software. It also provided technical
support where needed. For
example, the Teklynx integration team developed coding, formulas, and database
integrations that automated
the “country of origin” designation on product labels.
With its former labeling system, Aspen had to rely on
manual lookups and operator entry to designate the
country of origin on each
product label, a time-consuming and error-prone process. The new system automatically designates the country
of origin based on lot number, eliminating the risk of
human error on this critical labeling component.
Today, with the Teklynx Central CFR system in place,
labels are made using standard templates that are centrally
housed and managed by Aspen’s document-control department. Aspen team members anywhere in the world can
print them from a browser-based printing interface.
Among other advantages, the new system shaved weeks
off Aspen Medical’s label-approval process when dealing
with global contractors. “In the past, when our contractors
in China would make a label, we would send out label copy
and ask them to generate a label using their own system and
then send it back to us,” said Israel Lopez, planning manager for Aspen Medical Products, in a case study published on
Teklynx’s website. “This back-and-forth label-creation and
-approval process could take weeks.”
In addition to the time savings, the new system has
brought about a noticeable improvement in labeling accuracy, according to Aspen executives. Under the former
process, it was all too easy for production opera-
Seeking a cure
Aspen Medical Products finds the remedy for its labeling woes in Teklynx software.
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