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[EN] Success Story Pharmaceutical Industry

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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 contact@itris-automation.com for more information.

Published in: Engineering
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[EN] Success Story Pharmaceutical Industry

  1. 1. User Story CheckingthequalityofPLCprogramsinthepharmaceuticalindustry-1 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. Checking the quality of PLC programs in the pharmaceutical industry The use of PLC Checker by a large pharmaceutical company
  2. 2. User Story CheckingthequalityofPLCprogramsinthepharmaceuticalindustry-2 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. 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. THE CHALLENGE 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
  3. 3. User Story CheckingthequalityofPLCprogramsinthepharmaceuticalindustry-3 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. THE SOLUTION Itris Automation 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 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 framework.
  4. 4. User Story CheckingthequalityofPLCprogramsinthepharmaceuticalindustry-4 THE RESULT 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-a-Service tool facilitates the deployment of projects carried out with external partners," the Automation Manager explains. 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 MULTIPROG 5.50 • 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.
  5. 5. User Story CheckingthequalityofPLCprogramsinthepharmaceuticalindustry-5 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

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