A consolidated strategy is required to improve manufacturing process efficiency by harmonizing processes for electronic batch records (EBR) and electronic device history records (eDHR) for pharmaceutical and medical devices plants. This can help improve real-time visibility, data integrity and enhance data quality besides ensuring compliance and traceability. This article provides an overview on a case study for electronic batch records and electronic device history records process harmonization strategy.

The life sciences and medical devices industries are currently facing many challenges in a competitive global market. To maintain market position and meet customer demands, the organizations are under pressure to introduce new products early to the market with optimized costs. There is another challenge to conform to evolving local and global regulatory guidelines for ensuring manufacturing quality and minimizing product recall, which can be achieved by keeping track of batch records (BR) and device history records (DHR). Regulatory agencies emphasize keeping track of production details for each product manufactured by organizations, which is a cumbersome process, as management of BR and DHR is largely paper based, people dependent process in many organizations.

The manual processes take a lot of time and efforts and are often error prone, impacting overall costs and operations. Incorrect entries, unclear documents, rounding and calculation errors can significantly affect approval processes. Industry is exploring an efficient process to generate electronic, digitized batch record and device history records.

Business Needs

Data level

Improving manufacturing processes by replacing paper based mechanism with electronic data capture is utmost important.

Typical outcome at data level is:

1. Reduction of paper and human errors
   • An operator will work more effectively with all the process data to-be captured electronically, as he/she is experiencing time-consuming, error-prone data re-entry, resulting from multiple, disparate, and paper-based systems. Moreover, the operator will look for ways to minimize or eliminate human errors.
2. Assurance of Manufacturing Compliance
   • Quality management teams need to have a quick and efficient way to trace and review records for timely release of products. EBR/eDHR enforces the consistent execution of manufacturing steps while providing an accurate, real-time view of processes and deviation data. Apart from saving time associated with enforcing procedural compliance, an electronic system would streamline detecting, tracing, monitoring, closing, and documenting deviations in the manufacturing processes.
3. Improvement in Data Integrity and Process Verification
   • Plant manager needs to focus on overseeing daily operations of the plant and ensuring consistent production of high quality products. Plant manager role also entails improving productivity to reduce costs. Data captured in an electronic system will have the highest level of data integrity and enable automated review, shortening the cycle time for product release and preparation of batch records. Furthermore, electronic data would enable the formulation of strategies for improving product quality and process efficiency.

Plant level

Due to the unique nature of production processes across various manufacturing plants, data capture processes and compliance needs are inherently complex. Examples of these complexities include:

1. Different system requirements across various plants owing to legacy systems inherited from individual subsidiaries post mergers and acquisitions, with little corporate standardization.
2. Process similarities across different products and process variations between similar products
3. Historical process consistencies such as downtime trends, past deviations
4. Manual processes cause difficulties in traceability
5. Most of the data capture is either paper-based or manually entered into the electronic system.

Need of the Hour– Best Practices

EBR/eDHR implementation for batch records and device history records automation has become paramount and this can serve as a springboard for connecting the stakeholders for governance, data capture, and quality as well as providing a platform for manufacturing process improvement.

It is recommended that process mapping should be performed to identify and eliminate waste before the EBR implementation.

Industries are adopting some of the best practices to move towards digitization and automation of EBR and eDHR, which are discussed below.

1. Integration of EBR across systems such as manufacturing execution systems (MES), laboratory information management systems (LIMS), process control systems (PCS), quality management systems (QMS), ERP system and any solutions where data is recorded during batch manufacturing.
2. Deploy EBR as process engine to guide tasks and instructions for operations, also as a data hub for automated, real time data capturing for testing procedures, environmental monitoring, quality parameters, product life cycles and manufacturing automation data
3. Deployment of track-and-trace capability for eDHR regulatory. (Regulatory requirements for electronic batch records extend beyond manufacturing plant to the supply chain. The challenges create a need for more sophisticated and robust eBR capability)
4. Integration with quality management systems (QMSs) for corrective and preventive action (CAPA) and non-conformance workflows are required to be inextricably linked to the production process, in conformance with industry specific regulations
5. Weigh and dispense — build and implement capability for support of weigh and dispense, even before moving to electronic batch records
6. Enterprise-level reporting for serialized events, digital signatures, transaction datasets, mandated data standards and links to central regulatory and government repositories
7. Data management solutions for governance, randomization, storage and encryption
8. Dedicated workstations and functionality for serial number management, configuration and electronic packaging aggregation
9. Synchronization and harmonization across established ERP, automation and operational systems such as MES, transportation management systems (TMSs) and warehouse management systems (WMSs) with an extending visibility at edge processing transactions for managed efficiency of serialized transactional events.
10. Operational-line-level configuration for material flow, automation, scanning, routing and data capture through vision, inspections systems and high-speed camera technology
11. Interactive dashboards for serialization line and network planning
12. Manufacturing execution — process monitoring, in-process quality, the ability to dispatch, manage and control work based on global instructions from ERP, and supply chain planning/ execution suites
13. Warehouse management — raw material, work in process, finished goods, directed put-away and picking for make to order and ship from stock, remote warehouse support, vehicle pool management, and automated dock assignment
14. Equipment for scanning and data capture — integrated, fixed mount and handheld mobile devices
15. Data capture, physical interfaces such as RFID chips, pre-coded labels, packaging and substrates
16. Integrated inspection machines, line control and management systems often configured or customized (E.g., bottles, vials and secondary packages, serialized event capture reconciliation and reporting)
17. Specialized check weighing machines and packaging automation machines

Elements of Electronic Batch Records

Key enablers of EBR/eDHR for each benefit area and specific examples of improvements that will be realized when manufacturing execution and data capture moves from manual/paper based to automated/electronic are depicted in figure 1.

• Electronic Work Instructions / Data Entry à Reduction / Elimination of Paper Records
• Interface Source Data with SAP àImprovements in Data Integrity and Process Verification
• Interface Support Systems with Execution & SAP àAssurance of Manufacturing Compliance 

The technology layer in the figure 1 provides general descriptions of the types of applications cutting across multiple benefits “pillars” to enable EBR creation.

These descriptions are generic as there could be multiple technical pathways to achieve the endpoint. For instance, the requirements for a digitization solution can be met by applications with custom PI sheets in SAP or electronic work instructions and data capture.

Key Business Benefits

Manufacturing process harmonization and digitization benefits business with:

1. Digitization by reducing the use of paper-based data capture and eliminating human errors
2. Right First Time (RFT) time savings by reducing records review time of QA and supervisor
3. Enhanced data integrity, data quality, compliance traceability and conformance
4. Real-time, electronic data capture and review of process data
5. Improve batch release cycle time and reduction in production timelines
6. Automatic calculations for reconciliation and electronic management of audit trail
7. Increased compliance by reduction in deviations, non-conformances and associated investigations

Digitization of EBR and eDHR coupled with manufacturing process standardization can help improve compliance, data quality and data integrity, and enhance operational excellence and global collaboration.

Dr.Sarika Vanarse

Managing Consultant – Life Sciences & Medical Devices, Wipro Ltd.

Dr. Sarika is a Consulting leader with Wipro’s Health Consulting Life Sciences and Medical Devices practice focusing on driving business and technology transformation programs across value chain.

Dr. Sarika Vanarse can be reached at sarika.vanarse@wipro.com  

Dr. Rao Teki

Global Head - R&D Innovation and Transformation, Wipro Ltd.

Dr. Rao is a Consulting Partner and Global Head - R&D Innovation and Transformation focusing on driving innovation and transformation of R&D business.

Dr. Rao Teki can be reached at rao.teki@wipro.com