Line Execution System
Companies operating in the pharmaceutical industry have an obligation to produce safe, effective products, protect data integrity and comply with regulations. At the same time, companies need to ensure their processes are efficient and cost-effective.
Manufacturing processes that rely on tedious input, such as manual quality control tests, increase the chance for human error and introduce inefficiency. At COPA-DATA, we have developed our zenon Software Platform to help you combat pharmaceutical industry challenges, speed up production and streamline operations.
To help you achieve full line automation while generating high-quality products, our line execution system incorporates features such as central data management, alarming, and connectivity with third-party apps and devices like sensors. zenon can even detect deviations from good manufacturing practice and inform Quality Assurance in real time.
The challenges of pharmaceutical lines
Whether they are producing new drugs, conducting quality control checks or packaging products, pharmaceutical companies face unique manufacturing challenges. To succeed in this competitive industry, your pharmaceutical company needs to:
- Comply with regulations: To ensure compliance with global regulations, your company needs to take packaging into account. zenon enables enhanced product traceability through end-to-end serialization and provides accurate data about the products you manufacture.
- Digitize the plant: zenon covers certain Manufacturing Execution System (MES) functionalities vital to pharmaceutical plant digitalization, including recipe management, audit trail, historian, reporting and deviation handling. These features will prepare any factory for the next level of digital integration. If you already have an MES in place, zenon will integrate with it seamlessly.
- Connect isolated machines: Pharma production lines often contain machinery from multiple manufacturers and generations. When isolated, the units in the line can be challenging to control and maintain. As a hardware-independent software, zenon connects machines throughout your facility to provide one convenient point of access.
- Get products to market quickly: When developing a new drug, your company must reduce batch size and increase the number of product changeovers. Automating the production line with zenon could help you reduce changeover time while maintaining a high level of batch quality.
- Contain costs: To compete with other pharmaceutical companies, you need to keep production costs to a minimum. zenon keeps costs down by allowing you to create an effective Line Execution System out of the box. Additionally, zenon reduces financial risk by helping you comply with data integrity regulations and offers a low cost of ownership by extending the life cycle of your existing machines.
Benefits of zenon as a Line Execution System
zenon works as a standardized software solution from production up to packaging the pharmaceutical industry, allowing you to control, monitor, visualize and save data in accordance with regulations and customer requirements. zenon will benefit your pharmaceutical company by providing increased control over the manufacturing process and helping you produce products of consistent quality. You can also expect zenon to:
- Comply with all relevant regulations: zenon offers full compliance with FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines. These regulations relate to the proper use of electronic records and computer systems in the industry. As a configurable software system, it also meets GAMP 5 Software Category 4 requirements.
- Remove data silos: To allow for easy comparison and streamline record maintenance, zenon collects data from disparate machines and stores it all in one central location where you can easily access, backup, maintain and restore it.
- Adapt to international needs: zenon can support your production line no matter where you are located. The software features eight different languages, supports multiple PLC systems and can switch between units during ongoing operation, enabling it to adapt to the needs of international users.
- Provide visibility of the entire line: By connecting machines throughout the line, zenon makes it easy to oversee the entire production process. Using Batch Control, you can craft recipes without programming knowledge and monitor production at every stage.
- Reduce time for batch review: zenon records and analyzes batch data simultaneously, generating a single electronic batch report for the full line. As a result, you can release finished batches earlier, limiting the amount of money your company needs to spend on product storage.
- Integrate IT and OT: Bringing automation to IT services often proves challenging for IT and OT engineers. Our Line Execution System (LES) offers complete integration with Active Directory and other identity services and can be easily added to existing IT infrastructure. Additionally, hybrid scenario capability allows you to connect plants in different locations. zenon simplifies maintenance and makes upgrading to the newest technology easy.
- Improve data security: zenon features a robust security system that includes encrypted message communication, backwards compatibility and role-based user administration. The software also easily integrates with companywide identity services like Windows AD. As a platform compliant with the industrial security standard for secure product development lifecycle, IEC 62443, zenon closes loopholes at every stage of development, from design and implementation through product end-of-life.
Learn more about using zenon as a Manufacturing Execution System
At COPA-DATA, we make it easy for our customers to operate manufacturing equipment automatically. With 175,000 installations in more than 50 countries, we are uniquely positioned to help your pharmaceutical company produce and package safe, reliable products. To find out how zenon could solve your pharmaceutical line's challenges, contact us to request a free trial.