Electronic Batch Records for Paperless Pharma
Batch records are the foundation of quality control pharmaceutical manufacturing. While some still do this on paper, with the increasing complexity of drugs and regulations, many are turning to technology. And with good reason. But the transition from paper-based to electronic can be challenging when it comes to manufacturing. Employee pushback, system validation, and incomplete or inadequate identification of requirements can put your systems and processes at a higher risk of failure. Still, the benefits offered by Siemens Opcenter Execution Pharma and Electronic Batch Records for the modern life science business are real, significant and too compelling to ignore. When properly implemented and integrated with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems, Electronic Batch Recording can help you achieve efficiency, profitability and a competitive edge against all others.
Full Video Transcript
As one of the most challenging and regulated industry sectors, pharmaceutical manufacturing requires strict adherence to quality standards and process controls. For each batch produced, pharma companies are expected to document the entire process, from lab to label. In this way, they establish a Master Batch Record, or a trail of evidence showing that: 1 - the process operated within pre-established parameters and that, 2 - the product meets all specifications and quality attributes.
Batch records are the foundation of quality control in pharma manufacturing. While some still do this on paper, with the increasing complexity of drugs and regulations, many are turning to technology. And with good reason. The cost of compliance, the burden of paperwork and the risk of error can be reduced significantly with the use of Electronic Batch Recording, or EBR, software. As a leading system integrator and expert for Digital Manufacturing, Engineering Industries eXcellence leverages Siemens Opcenter Execution Pharma to deliver cost-effective EBR solutions to pharma and cosmetics manufacturers of all shapes and sizes.
EBR Design: With Opcenter Execution Pharma, users can design batch records via an intuitive workflow interface. Simple drag-and-drop components enable not just your programmers and IT experts, but all your process experts, to easily build and maintain them.
EBR Execution: Opcenter guides operators through the execution of a batch record step by step, collecting process data along the way using a combination of manual input and automatic capture. At every step, the system enforces pre-defined business rules to ensure that the process is executed right the first time.
Material and Lot Management: Material and lot definitions can be managed directly by Opcenter. Alternatively, the system can be integrated with your ERP or Warehouse Management System. Standard weighing and dispensing screens enforce quality control status and other critical lot attributes to ensure that the right quantity of the right material is used during the right process step.
Equipment Status Management: Tanks and other equipment can be modeled in the system to allow for automatic enforcement of hygiene status and other critical lifecycles. Integration with existing automation systems enables the automatic collection of process parameters and seamless communication of order statuses between top floor and shop floor.
Alerts and Deviation Management: Opcenter automatically detects exceptions and process deviations, flagging them for quality review when appropriate.
EBR Review and Release by Exception: The system puts all relevant details at the reviewer’s fingertips, giving users clear visibility into the issue, so they can focus on the resolution. Release-by-exception means no wasted time reviewing process steps that were executed without any issues.
The transition from paper-based to electronic can be challenging. Employee pushback, system validation, incomplete or inadequate identification of requirements can put your systems and processes at a higher risk of failure. But the benefits offered by Electronic Batch Records for the modern manufacturing business are real, significant and too compelling to ignore. When properly implemented and integrated with ERP and MES systems, EBR software can help you achieve efficiency, profitability and a competitive edge against all others. Engineering Industries eXcellence can help.
