Devices: Using MES
to Make Compliance Easier
By Francisco Almada Lobo, CEO, Critical
Compliance to regulatory stan- dards is an absolute priority for manufacturers of medical devices.
Non-compliance is simply not an option
for this market area. This article explains
how modern Manufacturing Execution
Systems (MES) help with this compliance and keep operations running
smoothly and efficiently.
A MES will facilitate configuration,
tracking, history, and compliance of
software throughout a factory. As part
of its many capabilities, it will track
manufacturing processes, components,
equipment, and people in order to
enable efficient resource management
and production scheduling. It will
control and document production processes to show that these have been
carried out correctly to comply with
industry standards and government
Compliance involves identification of
the product being made, including what
components are being used, and who
the people are who are working on it.
It requires verification steps to ensure
the correct processes are being utilized.
Any exceptions from the norm need to
be documented and appropriate action
taken. Everything that is happening
needs to be clearly documented and
time stamped. Depending on the local
regulations and devices being produced,
records may need to be stored for anywhere from 20 to 50 years.
To help achieve compliance, MES
can help in all four of these areas: Identi-
fication, verification, exception handling,
Unique device identifier (UDI) codes
are required by The U.S. Food and
Drug Administration(FDA) to track unit
assembly. A MES can automatically
generate a UDI that can be utilized in
processing, associated with the history of a particular product batch, and
used to identify the unit through any
Documents pertaining to procedures,
processes, equipment, regulations etc.,
can also be version controlled and stored
within the MES. They can be attached at
any point of the processing stream. The
document can be just a reference or a requirement that the operator must review
prior to executing a particular process.
At any stage during manufacture, the
MES can further request that the oper-
ator “sign” that they have performed a
task. This form of electronic signature
includes the name of the operator and
a password only known to them to
uniquely identify them as having carried
out the task. The system handles control
of passwords in line with 21 CFR Part
11 including password ageing, automatic
log-off, and password quality.
The MES can offer complete control over
the verification that all processes, personnel, and machinery are as they should be.
It can incorporate and record operator
certification, equipment maintenance records, recipe management, and verification
that correct components are being used.
At any stage in a process, an MES
can request verification that the specifications of parts or components are
within limits. This can include capturing
values of process variables that will be
Figure 1. Compliance and Traceability Made Easy with Manufacturing Execution System