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The pharmaceutical industry is subject to strict regulatory requirements when taking a product to the market. A large French pharmaceutical group wants to improve their compliance with rules and standards through PLC programming, without using manual code review.
This group contacted Itris Automation : PLC Checker was identified as the solution to automate code review for the project.
Find out now how checking the quality of PLC programs can help in the pharmaceutical industry.
Find us at http://www.itris-automation.com/
Contact us at firstname.lastname@example.org for more information.
The pharmaceutical industry is subject to strict
regulatory requirements when taking a product to
A large French pharmaceutical group wants to
improve its compliance to rules and standards
through PLC programming, without using manual
PLC Checker is identified as the solution to
automate code review for the project.
After successfully using PLC Checker, the client
decides to systematically use the software tool
inside the group.
Checking the quality of PLC programs
in the pharmaceutical industry
The use of PLC Checker by a large pharmaceutical company
The pharmaceutical industry is subject to strict regulatory requirements. In other
words, a drug can only be marketed if its quality has been approved by a national
regulatory authority. Regarding the automation systems used in this industry, three
elements must be tried and validated: the documentation of the correct functioning
of the installation according to a specific standard; the traceability of any modification
or evolution made through accreditation; the maintenance of these validations over
time. Automated systems typically need many standards and rules to ensure the
control of the design and implementation.
Itris Automation was approached by a large French pharmaceutical group to help
them improve the compliance of their PLC programs with rules and standards.
Historically, the method used to verify their compliance with standards was through
manual code review (rules, test sheets). But this technique had limitations: the
relevance and accuracy of the review was largely subject to human errors, and the
result was never exhaustive due to the large number of code lines. A heavy and
expensive process in the case of large programs. The resulting profitability (ROI) of
this manual review was therefore unsatisfactory.
In 2012, the group’s technological watchdog informed their Automation Manager of
the existence of a static analysis tool for PLC programs: PLC Checker, developed by
the Grenoble-based company Itris Automation. PLC Checker is a collaborative
application that provides automatic static code analysis for the quality management
of PLC programs. PLC Checker detects PLC program abnormalities, optimizes code
efficiency and verifies compliance with coding rules. Schneider Electric, EDF, Areva,
Renault, and Engie are some of the users of this software tool.
PLC Checker was identified as
the solution to automate their
code review. The Automation
Manager explains: “When an audit
is performed by control engineers
with each their own habits, the end
result is that two experts oppose each other. Their battle can take months to solve.
PLC Checker simplifies the audit and ends the debate. In our industry, it is easier to
sell quality assurance tools rather than human expertise, subject to interpretation.”
The Manager and his team decided to test PLC Checker on an existing
production site that was being upgraded. It involved the replacement of a DCS
system by a Siemens S7 / Wonderware WSP PLC-based automation solution. The
codes of ten 7-400 PLCs with a volume of 7500 input-outputs were checked. To
minimize delays, the code was divided between six different integrators – with
potentially divergent practices. To add to the project’s complexity, the site’s existing
system needed to be replaced and the production process changed, in order to
reduce short term risks in the modification of the PLC. This project was therefore an
ideal one to test the relevance of PLC Checker as a tool for code review.
Itris Automation and the
client’s teams quickly
worked together to
PLC Checker, following a
approach. The client
began by presenting its
standard and coding
rules to the Grenoble
team, so that they had
the necessary data to
establish rules for PLC Checker. The Itris Automation team then presented their
standard rules which could potentially suit their client’s needs. A first test was
performed on a referral program to highlight the potential differences. Itris Automation
then finalized the client’s rules on PLC Checker. The programs provided by the six
system integrators were tested and corrected, and the client finally integrated specific
rules for its coding standard.
To implement PLC Checker, the Automation Manager and his team spent 3 weeks
defining the rules. A lengthy but single effort if the rules and standards are perennial.
“PLC Checker helped us improve our rules; we realized they weren’t necessarily well
written,” the Automation Manager explained. The software tool offers a platform and
a language-independent technological framework. Quality Assurance teams
appreciate that it uses objective criteria for code acceptance. It’s therefore an ideal
solution in the pharmaceutical and biotechnology sectors. PLC Checker showed
compliance between programs and rules in an automatic and replicable way, cheaper
than the usual manual method.
PLC Checker offers a platform and a language-independent technological
After successfully using PLC Checker, the client decided to systematically use
the software tool across the
group, including for
developments by remotely
"A Software-as-a-Service tool
facilitates the deployment of
projects carried out with external
partners," the Automation
In addition, the deployment of
this approach will provide better statistical information, in order to trace quality
improvement, and, ultimately, help control the entire base of PLCs.
PLC Checker is available for
• CoDeSys v2.x, v3.x
• Beckoff TwinCAT 2 and 3
• ICS Triplex ISaGRAF 4.12
• Phoenix Contact PC Worx and
• PLCopen XML
• Rockwell Automation RSLogix 5,
RSLogix 500, and RSLogix 5000
• Schneider Electric Unity Pro, PL7 Pro,
Orphee, XTEL, and SoMachine 4
• Siemens Step5, Step7, and TIA Portal
• Yokogawa Stardom
After successfully using PLC Checker, the client decided
to systematically use the software tool across the group.
About Itris Automation
Based in Grenoble, France, Itris Automation is a software engineering company that
provides development and production tools for the verification, conversion,
documentation and troubleshooting of PLC codes to complement the programming
tools of international PLC vendors. Thanks to their advanced technologies, Itris
Automation helps companies improve their development processes and thus deliver
higher quality programs in shorter timeframes. The Itris Automation team are experts
in software quality and coding standards, and they have combined their knowledge
and skills to provide innovative solutions for the industry.
Schneider Electric, EDF, Sanofi, Ford, Eiffage, Soitec, and ArianeGroup are among
Itris Automation’s main customers.
For more information, please visit our website www.itris-automation.com