Back
Back
Electronic Batch Records for Paperless Pharma
3
min watch
Batch records are the foundation of quality control in pharmaceutical manufacturing. While some organizations still rely on paper-based processes, increasing drug complexity and regulatory requirements are driving many toward technology-based approaches. The transition from paper-based to electronic batch records can be challenging, particularly in manufacturing environments where employee resistance, system validation requirements and incomplete or inadequate definition of requirements may increase the risk of failure.
Despite these challenges, the benefits of Siemens Opcenter Execution Pharma and electronic batch records for the modern life science business are significant. When properly implemented and integrated with Manufacturing Execution Systems and Enterprise Resource Planning systems, electronic batch recording supports improved efficiency, profitability and competitiveness across pharmaceutical manufacturing operations.
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:
– the process operated within pre-established parameters and
– 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.
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, IndX leverages Siemens Opcenter Execution Pharma to deliver cost-effective EBR solutions to pharma and cosmetics manufacturers of all shapes and sizes.
With Opcenter Execution Pharma, users can design batch records via an intuitive workflow interface. Simple drag-and-drop components enable not just programmers and IT experts, but all process experts, to easily build and maintain them.
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 definitions can be managed directly by Opcenter or integrated with ERP or Warehouse Management Systems. Standard weighing and dispensing screens enforce quality control status and critical lot attributes to ensure the right quantity of the right material is used at the right process step.
Tanks and other equipment can be modeled in the system to allow automatic enforcement of hygiene status and other critical lifecycles. Integration with existing automation systems enables automatic collection of process parameters and seamless communication between top floor and shop floor.
Opcenter automatically detects exceptions and process deviations, flagging them for quality review when appropriate.
The system places all relevant details at the reviewer’s fingertips, giving clear visibility into issues so users can focus on resolution. Release-by-exception eliminates wasted time reviewing steps executed without issues.
The transition from paper-based to electronic can be challenging. Employee pushback, system validation and incomplete identification of requirements can increase the risk of failure.
The benefits of Electronic Batch Records for modern manufacturing are real, significant and compelling. When properly implemented and integrated with ERP and MES systems, EBR software can help achieve efficiency, profitability and a competitive edge.
