Electronic batch records and the process of their design and implementation within a multi-product biopharmaceutical facility in Ireland

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O'Driscoll, Jean
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The dissertation relates to electronic batch records and the process of their design and implementation within multi-product biopharmaceutical facilities. This dissertation outlines the

position of electronic batch records (eBR) in the current age of digitisation within the biopharmaceutical industry. It presents the benefits that can be obtained through eBR implementation, particularly in the realm of compliance and right-first-time execution. It presents the quantity of paper record reduction within a single biopharmaceutical facility. It also outlines the challenges introduced with eBR implementation and the requirements for companies to adopt

practices and processes to realise the associated benefits. This research was focused within a single

company comprising of numerous biopharmaceutical facilities on one site located in Ireland.

This dissertation identified the technical hurdles that must be overcome during eBR implementation, and also the organisational barriers that could impede successful implementation. Data was collected across organisational hierarchies via an online survey (N=119). This survey aimed to collect data as it relates to (i) internal attitudes towards eBRs, (ii) eBR familiarity, (iii) ease of eBR adoption, (iv) understanding of eBR processes, (v) understanding of eBRs compared to paper records

and, (vi) time/experience impact on eBR attitudes. This data was analysed to identify relationships between organisational role/functional role and the areas of investigation. Qualitative data was also collected via a series of semi-structured interviews (N=11). These interviews were completed with

subject matter experts (SMEs) in eBR implementation and participants were either presently or previously involved in an eBR implementation project. They were conducted across technical and

management personnel who were identified as either (1) business SMEs, experts in paper batch record content and production processes or, (2) eBR SMEs, personnel familiar with IT requirements to enable the translation of paper process to electronic. The interviews aimed to gather information across the following areas, (i) role in eBR implementation (ii)understanding of drivers for eBR implementation(iii) priority of eBR implementation within the business, (iv) challenges and benefits associated with eBR implementation, (v) structure of eBR implementation, and, (vi) behavioural and technical challenges of eBR implementation. The output from the surveys and interviews was interpreted to establish research findings associated with this dissertation.

The research found that the implementation of eBRs is a complex process, and its success is not

depending on a single variable. Findings showed that both technical and organisational challenges exist, and improvements can be made by addressing both areas. The research revealed the

compliance benefits obtained through eBR implementation. It also demonstrated the significant time saving and streamlining effect of eBR in the process of batch release. However, this research also showed a need for an internal mindset change to the eBR implementation approach. It indicated a requirement for processes and practices to evolve to enable both eBR implementation and maintenance into the future. This research demonstrated the importance of understanding gaps within the current process and potential risks associated with knowledge management and training in eBRs. This dissertation’s research findings present an opportunity to adapt current approaches to eBR implementation to enable the benefits of eBR implementation within the organisation

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