The Changing Face of
International Business Systems’ approach to ERP systems
in light of the DSCSA requirements.
By Meg Snyder, Editor
Effective in January of 2015, pharmaceutical distributors were required to report the chain of custody of the products they sell: who
they acquired the drug from and who they
sold the drug to. In 2017, the track-and-trace
requirements become much more complex
for the pharmaceutical distributors, as they
must report this same chain of custody at the
serial number level of the individual drug.
As a result, many companies are now
seeking out pharmaceutical-specific enterprise
resource planning (ERP) solutions to support
their operations. The same traceability
infrastructure has to be in place for a
company with 5 employees and 5 thousand
“It’s a lot of information for small- and mid-sized
companies,” said Michael O’Brien, VP-Americas at
International Business Systems (IBS)—a mid-market
distribution ERP software company.
“The requirements to stay compliant are pretty
onerous for a small- to mid-sized distribution
company,” said O’Brien. “It’s also very expensive
for a pharmaceutical distributor to modify their
system to be compliant and have the reporting
agencies that they are requiring.”
The pharmaceutical distributors have to report to
the unit number: how long they have had it, who
they have sold it to, and the chain of custody down
to the unit of drug.
“Most ERP systems don’t currently track down
to the serial number of a product,” said O’Brien.
One of the concerns that companies expressed
with regards to the DSCSA requirements, according
to O’Brien, is how they know if software is
compliant with legislation. This is largely due to
the consequences if a company is not compliant—
the DEA can revoke the license of a pharmaceutical
“It’s a compliance-driven industry, and it should
be by its nature,” said O’Brien.
But how can small- and mid-sized companies
work toward the implementation of these
What Do (and Will) Pharmaceutical
Distributors Need to Keep Track of?
In its ERP system, IBS has some key features that
aid pharmaceutical distributors in keeping track of
the following information pertaining