The pharmaceutical industry is subject to strict regulatory requirements when taking a product to the market. A large French pharmaceutical group wants to improve its compliance to rules and standards through PLC programming, without using manual code review. This group contacted Itris Automation Square : PLC Checker was identified as the solution to automate code review for the project. See now how checking the quality of PLC programs works in the pharmaceutical industry. Enjoy the reading! Find us at http://www.itris-automation.com/ Contact us at commercial@itris-automation.com for more information.

1. U User story
Checking the quality of PLC programs
in the pharmaceutical industry
A large pharmaceutical company uses PLC Checker
The context
The pharmaceutical industry is subject to strict
regulatory requirements when taking a product
to the market.
The challenge
A large French pharmaceutical group wants to
improve its compliance to rules and standards
through PLC programming, without using
manual code review.
The solution
PLC Checker is identified as the solution to
automate code review for the project.
The result
After successfully using PLC Checker, the
client decides to systematically use the
software tool inside the group.
THE CONTEXT
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. More specifically, three elements must be tried and validated:
the correct functioning of the installations towards a given repository; 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 control design and implementation.
Checking the quality of PLC programs in the pharmaceutical industry – 1/4

2. U User story
THE CHALLENGE
Itris Automation Square was approached by a large French pharmaceutical
group to improve their rules and standards compliance with PLC programming.
Historically, the method used to improve 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 its Automation Manager of the
existence of a static analysis tool for PLC programs: PLC Checker, developed by the
Grenoble-based company Itris Automation Square. PLC Checker is a collaborative
cloud application that provides automatic static code analysis for PLC programs
quality management. PLC Checker detects PLC programs abnormalities, optimizes
code efficiency and verifies compliance with coding rules. Schneider Electric, EDF,
Safran, Areva, PSA Peugeot Citroën are some of the users of this software tool.
PLC Checker was identified as
the solution to automate code
review.
The
Automation
Manager explains: “When an
audit is made by control
engineers with each their own
habits, the end result is that two experts oppose each other. This experts 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
building that was being upgraded. It involved the replacement of a DCS system by
a Siemens S7/Wonderware WSP PLC-based automation solution. Ten 7-400 PLCs
and 7500 input-output codes 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 building’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.
Checking the quality of PLC programs in the pharmaceutical industry – 2/4

3. U User story
THE SOLUTION
Itris Automation Square and the client’s teams quickly worked together to implement
PLC Checker, following a steady
step-by-step 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 Square team then
proposed a potentially suitable
program for the client’s needs. A
first test was performed on a
referral program to highlight the
potential
differences.
Itris
Automation Square then finalized
the client’s rules on PLC Checker.
The programs provided by the six
integrators were tested and
corrected, and the client finally
integrated specific rules for its
PLC Checker offers a platform and a languagecoding standard.
independent technological framework.
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.
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4. U User story
THE RESULT
What came out of this collaboration? After successfully using PLC Checker, the
client decided to systematically use the software tool across the group,
including for developments
by
remotely
located
integrators. "A software-as-aService tool facilitates the
deployment
of
projects
carried out with external
partners," the Automation
Manager explains.
In addition, the deployment
of this approach will enable
After successfully using PLC Checker, the client decided to
better statistical information,
systematically use the software tool across the group.
in order to trace quality
improvement, and, ultimately, help control the entire base of PLCs.
PLC Checker is available for
o Schneider Electric Unity Pro and
PL7 Pro
o Siemens Step 5 and Step 7
o CoDeSys v3.2
o Rockwell Automation RSLogix
5000
o PLCopen XML
About Itris Automation Square
Based in Grenoble (France), Itris Automation Square (IAS) is a software
company providing products for the conversion, verification and documentation of
PLC programs. Through advanced technologies, IAS allows its clients to improve
their development process, save time and write better programs faster.
For more information, visit www.automationsquare.com/
Contacts
Mrs Valerie FONTAINE, Director of Business Development, EMEA
 valerie.fontaine@automationsquare.com  +33 (0)6 52 69 97 52
Mr Sangmin LEE, Director of Business Development, Asia and Americas
 sangmin.lee@automationsquare.com  +33 (0)7 78 87 90 36
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