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[EN] Success story pharma

A large pharmaceutical industry uses PLC Checker

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[EN] Success story pharma

  1. 1. U User story Checking the quality of PLC programs in the pharmaceutical industry – 1/4 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 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.
  2. 2. U User story Checking the quality of PLC programs in the pharmaceutical industry – 2/4 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.
  3. 3. U User story Checking the quality of PLC programs in the pharmaceutical industry – 3/4 PLC Checker offers a platform and a language- independent technological framework. 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 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.
  4. 4. U User story Checking the quality of PLC programs in the pharmaceutical industry – 4/4 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-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 enable better statistical information, 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 After successfully using PLC Checker, the client decided to systematically use the software tool across the group. 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