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Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.
An electronic batch record provides proof that an organization properly handles and records all critical steps to produce each batch of a product, whether entered electronically or manually. This record includes data associated with operators, the manufacturing process, equipment, materials, and supplies. It can also include data from laboratory information management systems (LIMS), enterprise resource planning (ERP), process control systems (PCS), and more.
From a compliance standpoint, an electronic batch record solution helps an organization meet 21 Code of Federal Regulations (CFR) Part 11, which defines the manner in which FDA accepts electronic records and electronic signatures (1).
By putting electronic batch records in place, an organization sees benefits that relate to improved data integrity and accuracy, streamlined processes, and efficient operations. Optimizing these processes yields improved resource management, improved inventory management, and reduced material losses-all of which positively impact the operation’s bottom line.
But what must an organization consider when beginning the journey to implement an electronic batch record solution? Evaluation of the following areas is crucial:
Cultural aspects are significant for an organization to consider when preparing for electronic batch records. The changes required for the successful implementation of an electronic batch record affect personnel throughout a company and include how people work with each other, how data are used, how data integrity is maintained, and how processes are implemented. Operators, engineers, and maintenance personnel must be trained to complete the right activities and access the right data at the right time.
Before training can begin, managing cultural change must be well planned and include communications across all areas of an organization. Input should be solicited from stakeholders and business direction should be given to multiple audiences.
Management must communicate the overall organizational direction and why this change is important. Plant-floor personnel will therefore understand why changes are occurring, and they will recognize the value of the changes in their daily responsibilities. Ultimately, the cultural shift needs to be management driven and accepted across the enterprise.
At the same time, plant-floor personnel have deep process expertise that management likely does not possess. Therefore, although management must drive the electronic batch record initiative and the accompanying changes, plant-floor experts need to help set the requirements that ensure a smooth transition. Plant-floor personnel must provide input to assess how changes will affect work processes; they will also help craft a workable and well-accepted electronic batch record solution.
Managing organizational culture change is most successful when personnel from many areas of expertise are involved in making decisions and in building an implementation plan. A good start to the initiative is found in a participatory workshop environment that encourages team members to see their personal stake in the changes and recognize the benefits to them and to the organization. The workshop can bring value when the participants:
A true electronic batch record captures-in digital form-all information entered electronically or manually. Manually entered data that are critical to the process need to be verified by a second person if it is not readily available for verification inherently by the system. All systems in an enterprise must enforce data integrity so that the data in the electronic batch record can be considered accurate and dependable. Data integrity is about ensuring that data are taken from the right place and recorded in the right way. It means data are attributable, legible, contemporaneously recorded, an original or true copy, and accurate (ALCOA).
To maintain an environment of digital integrity and support electronic batch record accuracy, all personnel--new or experienced, management or plant-floor--must follow procedures consistently as directed per the procedure. To ensure that data cannot be tampered with or manipulated, an organization must build a data-integrity strategy into each of these business processes:
The following topics should be well understood and processes should be set in place to maintain data integrity. Each topic is a subset of the four business processes mentioned previously and must be in place to support electronic batch record processes:
An electronic batch record solution resides in layer three of the ISA-95 model; the layer includes production dispatching, detailed production scheduling, reliability assurance, and other manufacturing execution functions. Electronic batch record solutions can provide an integrated environment that pulls together information from ERP, LIMS, quality management systems (QMS), distributed control system (DCS), and other control systems. Data from the relevant systems are presented to the operator in the correct context providing them with a central location to capture their electronic batch records. Technology infrastructure should provide all the security and personnel management tools required to meet the established business process goals.
To prepare the organization for electronic batch records, technology solutions must be evaluated to fit the situation. Process set up and process control scenarios as well as integration to higher level systems should be considered. The technology must be applied per the practical needs of various operating scenarios. Often, several solution scenarios will be used for various types of operating plants and even within a plant.
As such, a set of guidelines should be established to cover how to apply the technology, and the integration should match the needs of the facility. These guidelines should cover practices associated with the level of shop-floor automation, workflow philosophies, and workflow integration. For example, consider the following different needs of manual or automated processes:
Any technology solution should be able to validate that the data adhere to the ALCOA principles. Utilizing systems and devices that send data digitally to the electronic batch record solution with requisite checking capabilities is helpful so that manual data entry and verification is not required.
Many people must be involved in preparing the culture, the processes, and the technology for an electronic batch record solution. Although the associated considerations and implementation activities are not trivial, the risks and expenses of not implementing an electronic batch record solution far outweigh the costs of implementing it.
Without an electronic batch record solution in place, the short- and long-term effects can include rising costs of business operations and potential product quality issues that could have otherwise been prevented. Without the batch record solution, an organization pays for manual compliance, manual documentation, manually dealing with errors, manually tracing actions, and manually gathering/reviewing all information about deviations.
Instead, with an electronic batch record solution in place, an organization can look forward to an easier means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation with product. All of these benefits add to a swift return on investment.
1. FDA, 21 CFR Part 11, Electronic Batch Records, 62 Federal Register 13464, Mar. 20, 1997.
Vol. 42, No. 4
When referring to this article, please cite it as S. Schniepp," Pharmaceutical Technology 42 (4) 2018.