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Pharmaceutical companies have to ensure compliance with legal regulations at all levels of the production process while also being fast and competitive. Werum PAS-X MES, the industry-leading manufacturing execution system (MES) from Körber, ensures that this occurs completely digitally without any paper-based processes. It simplifies documentation, accelerates work processes, and improves the quality of products and processes.
Digitization enables pharmaceutical and biotech companies to make processes more efficient, safer, and simpler. However, a corresponding infrastructure is needed to make this possible. The software product Werum PAS-X MES from the Körber Business Area Pharma serves as companies’ “digital backbone” with which they implement their strategies for Pharma 4.0.
“Thanks to its Right First Time feature, Werum PAS-X MES improves the quality of products and processes by as much as 98 percent — and it does so from its very first use,” says Clémentine Tassaux, Associate Principal Production IT Software, Körber Business Area Pharma. The MES controls, monitors, and synchronizes production processes in real time and communicates on all levels with the connected systems and facilities. Via terminals or mobile devices such as tablets, PAS-X MES guides users through the entire manufacturing process and supplies important data and information. “As a result, companies can rest completely assured that the prescribed standards are met at every stage of production,” says Clémentine Tassaux.
The networking of production facilities and machines generates huge flows of data. Körber’s PAS-X MES system evaluates this data and monitors all production and packaging lines in real time. One of its key functions is electronic batch recording. This enables recipes – or master batch records (MBRs) – to be executed as electronic batch records (EBRs) and production and documentation processes to be carried out completely digitally. “As a result, there is no longer any need to fill out paper sheets by hand,” explains Tassaux. “This speeds up processes and reduces the number of batch deviations by up to 20 percent because there are fewer transmission errors.”
PAS-X MES enables many processes to be automated, including the evaluation of individual process steps and procedures and the assignment of process data to process events. In addition, automatic data evaluation allows companies to introduce a review-by-exception process. “Our MES automatically checks the batch reports during running production and approves them if they meet the corresponding requirements. This reduces the work load for the quality assurance employees and accelerates their processes,” says Tassaux. Only the records in which the MES has detected deviations from the standard process are forwarded to the quality assurance so that they can be checked and approved.
This shortening of review times and safeguarding of a plant’s internal material flow also benefits time-sensitive sectors such as the producers of cell and gene therapies. “In a production environment in which each patient represents a single batch and time is of the essence, PAS-X MES reduces the risk of mix-ups and ensures that the pharmaceuticals are available on time for treatment,” says Tassaux. For example, it takes almost 30 hours on average to check a paper-based batch record for a CAR-T customer. By contrast, the use of PAS-X MES reduces the time needed for this process to only about four hours. To enable the MES to be integrated into the processes of cell and gene therapy production as smoothly as possible, the Körber Business Area Pharma has developed special cell therapy content so that 70 percent of a company’s typical applications are pre-installed.
lThanks to Right First Time, Werum PAS-X MES improves the quality of products and processes by as much as 98 percent – right from the beginning.r
Clémentine Tassaux, Associate Principal Production IT Software, Körber Business Area Pharma
Moreover, the digitization of the processes and records makes new working methods possible. For example, employees can remotely create, check, test, and approve batch records from home. This enables production to keep on running in times of crisis, such as the COVID-19 pandemic, when parts of the workforce are working from home. Another advantage is that individual processes are easier to track. PAS-X MES documents the date and time of all executed process steps and records the participating employees according to their electronic signatures. It can do this with the help of smart bracelets, for example, or by means of biometric authentication in the form of fingerprints, iris scans, facial recognition, or a combination of those. This ensures that every work step can be traced back to the operator who carried it out. “The new digital procedures have provided many advantages to our site, including improvements to our production processes and data availability,” says Paul Keogh, plant director at Takeda Grange Castle.
PAS-X MES’s comprehensive electronic documentation also helps companies to monitor and manage their status lists, cleaning regulations, and histories of the various types of containers. Thanks to an augmented reality feature, the MES also improves format changes and line clearance on the shop floor. The application systematically guides operators through the respective processes by transmitting all of the required work steps into the worker’s field of vision via HoloLens data glasses. This increases the efficiency of refit processes by as much as 30 percent.
To make the step into digitized production easier, Körber offers key functions of the Werum PAS-X MES as modular entry-level solutions. This includes functions for the creation of master batch records, for weighing and dispensing of raw materials, and for recording key performance indicators in real time in order to boost production (KPI/OEE). “It thus enables companies to select and implement individual solutions and to expand them with additional functions later on,” says Tassaux. All of the functions are immediately usable, thus eliminating the need for costly customizations. The modular structure and preconfigured content ensure that PAS-X MES isn’t just suitable for big companies, but also for small and medium-size enterprises.
The MES from the Körber Business Area Pharma has proven its worth on numerous occasions and received many awards, including the Frost & Sullivan Customer Value Leadership Award and the Best Bioprocessing Software Award. In the Gartner report “Magic Quadrant for Manufacturing Execution Systems” Werum PAS-X MES was named a Leader. More than half of the world’s top 30 pharmaceutical and biotech companies use Werum PAS-X MES, as do a similarly large percentage of leading medium-size and regional drug manufacturers. Together, the PAS-X MES users form the world’s largest MES community within the pharmaceutical and biotech industries. Many of them are active in the “PAS-X Community” user forum and come together for Connext, the annual user meetings in Asia, Europe, and the USA. “We consider the MES from Körber to be a strategic system that gives us a competitive edge,” says a senior manager of the customer, a global leader in contract pharmaceutical packaging. Werum PAS-X MES enables companies to optimize their processes so that they are ideally equipped for future markets.
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