Electronic batch records enable pharmaceutical automation and paper elimination
In the intricate kingdom of pharmaceutical manufacturing, careful documentation is imperative at every stage. However, the reliance on paper records can be both time-consuming and susceptible to human errors. The pharmaceutical industry has included Electronic Batch Record (EBR) systems to streamline workflows and enhance accuracy. This article delves into how the innovative Process-XE system is transforming document creation across the pharmaceutical sector, from bulk processing to packaging.
Understanding Electronic Batch Records
Pharmaceutical companies opting for production solutions prioritize not only the digitization of forms but also seek to expedite form filling by automating data collection directly from machines. The comprehensive EBR solution covers a spectrum of processes, including product weighing, mixing, granulation, tableting, coating, packaging, and quality control. The system gathers data from various equipment such as scales and meters, minimizing the chances of errors and allowing real-time tracking of deviations from the norm during production. ProcessXE ensures compliance with Good Manufacturing Practice (GMP) standards.
The implementation of ProcessXE goes beyond digitizing documentation; it guides operators through the entire production process, including changeovers, quality control, logistics, and maintenance processes.
ProcessXE: An Advantage for Pharma
ProcessXE offers a complete system encompassing machine data acquisition, hardware, ERP integration, and infrastructure. Especially, it includes Master Batch Record (MBR) template creation, allowing clients to configure activities in the right sequence with defined roles and responsibilities. Each activity is customizable with reporting data types, such as numbers, text, and data read from automation, validated against preset quality limits.
Fields in the forms cover a range of parameters, including task completion status, production values, task duration, electronic signatures, and remarks by responsible personnel. The system equips every work center with an operator panel, facilitating actions like selecting production orders, confirming actions, electronic signatures, step-by-step instructions, documentation display, production progress monitoring, traceability, and Overall Equipment Effectiveness (OEE) analysis.
Integration with SAP is seamlessly achieved through web services, and additional production process details can be configured in the ProcessXE Master Data module.
The Paperless Pharma Process
A paperless approach involves digitally guiding operators through production stages, displaying activity to-do lists, changeover information, and dedicated documentation for each step. ProcessXE Forms automates the filling of sheets, tables, and reports with real-time shift data, issuing timely task completion notifications and monitoring changes and deviations with an audit trail.
Mobile barcode scanners ensure validation and traceability of materials, with the system supporting label printing for boxes or containers. During sample testing, the system prompts the creation of new samples, generates labels for scanning in the laboratory, and automatically compares test results against set quality tolerances.
The batch approval process in ProcessXE mandates electronic signatures at each step, providing a transparent workflow. Notifications alert relevant roles, enabling personnel with the right permissions to monitor progress and KPIs for batch releases.
Benefits for Pharma Businesses
Implementing EBR with ProcessXE brings substantial benefits to pharmaceutical businesses. A 35% reduction in batch release time is achieved through workflow optimization and automated data gathering. Material validation, periodic quality checks, and digital instructions contribute to a 15% reduction in errors and waste. Additionally, On-Time-In-Full performance sees a 7% improvement.
EBR implementation fosters faster communication between departments, eliminates paper from production processes, and provides continuous monitoring of batch release statuses. ProcessXE emerges as a solution that not only enhances operational efficiency but also aligns with environmental sustainability goals.
For more details on batch records feel free to reach out to a member of the ProcessXE team.
