By Martin Gore, European Business Development Manager – Digital Manufacturing
The pharmaceutical sector is undergoing a significant business and digital transformation due to increased industry regulation. The U.S. Drug Supply Chain Security Act (DSCSA), the European Union Falsified Medicines Directive (EU FMD) initiative, Russian Law 425-FZ and other country regulations seek to combat counterfeit drugs with the introduction of mass serialization. These and other regulatory requirements add a layer of complexity for manufacturers, especially if many of the processes are manual or paper-based. There are technology solutions, however, that can assist and offer a competitive advantage in a crowded global market. The purpose of the electronic batch record (EBR) is to document that a company properly handles and records all critical steps to produce each batch of a product. EBR systems collect and record data associated with:
The electronic batch record also includes the wider scope of data and processes managed with laboratory information management systems (LIMS), enterprise resource planning (ERP) and process control systems (PCS).
Today, many regulated businesses operate in a hybrid manner of using a combination of business systems such as ERP, but still heavily rely on capturing data on paper-based systems via manual business processes and functional or departmental data held in disconnected silos. To compete against local and global competition, connecting the shop floor to the top floor while capturing data at the source and in real-time is paramount.
Many enterprises understand the benefits of digitalization by connecting the shop floor and product-related operations to the rest of the business, as well as the disruption that comes with this change. It requires using Industry 4.0 and IIoT principles to integrate in order to bring factory operations and processes online in real-time. Therefore, this type of business transformation requires director-level ownership and sponsorship. It also requires buy-in from all departmental and functional stakeholders and shareholders.
If the company chooses to embrace a dynamic change by implementing electronic batch records (EBR) supporting 21 CFR Part 11 compliance, operations will:
The automatic process results in documentation used for operational analyses as well as regulatory compliance. There are many benefits associated with implementing an electronic batch record solution, for example:
All these factors impact the financial bottom line.
There are industry solutions that interoperate seamlessly together, presenting data from SAP and non-SAP data sources into a single operator user interface (as well as posting data back to create a closed-loop system).
They pull information from SAP ERP, SAP Quality Management, SAP Plant Maintenance, SAP Inventory Management and other applications, such as external LIMS and Historians populated with data from devices attached to machines. These solutions often include:
Implementing an electronic batch record is a journey with a clear destination. By leveraging smart industry applications, such as Movilitas’ ISA95 compliant smart industry solutions designed for SAP MII, manufacturers can define an agile EBR project roadmap. However, rather than an all-or-nothing approach, the enterprise can start with a specific business use case, such as recipe management. This agility creates a quick win that increases the immediate value as well as reduces concerns about the project.
Once the first step is completed, the next project cycle can start, for example weighing and dispensing. Each completion moves the manufacturer closer to full suite implementation. The result is being able to capture all the data required and automatically create an all-encompassing EBR.
Without an electronic batch record solution in place, there are several short- and long-term effects, such as rising costs of business operations and product quality issues, that could be prevented. The enterprise continues to operate in manual mode for all processes:
Any manual data capture creates an overhead for the business to achieve full traceability.
Instead, with an electronic batch record solution in place, the enterprise can create a single version of the truth, achieve compliance easier, reduce errors and increase data integrity and accuracy. In addition, EBR offers real-time traceability while simultaneously generating product and batch documentation.
Download our guide, How to Grow with Digital Manufacturing & Electronic Batch Records, to discover how to implement an electronic batch record solution in your operation. Ready to move forward? Contact our Movilitas experts.
