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Cyber security: A standard CMDB data model for pharmaceutical manufacturing shop floor systems

Pharmaceutical manufacturers are developing and using Configuration Management Databases (CMDB) to maintain inventories of the IT and automation assets used by the manufacturing and laboratory systems at their production facilities. A CMDB can provide access to accurate data, including available assets, where they are, how they are configured, and the relationships that exist between them; all of which are vital functions for lifecycle management, change management, incident management and patching.

The information model typically used by the standard CMDB installation is based on the idea that all systems used by the enterprise are software based and described by a class of objects called an application. This does not always align to the needs within an operations technology (OT) environment. Therefore, the BioPhorum Cyber Security members, using their extensive combined knowledge, have collaborated to design a common information model describing a manufacturing system detailed in a shop floor/OT CMDB. The proposed model is intended to be a free, reusable, standard structure which can be adapted for specific company needs, providing a good starting point for configuration data modelers working in the OT space.

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Smart maintenance: digital evolution for biopharmaceutical manufacturing

The pressures to achieve more with less in the world of equipment and facilities maintenance has always been there, but what part can smart maintenance and the use of digital technologies do for us? What would an investment deliver in terms of lower costs and improved asset utilisation? This paper defines what ‘smart maintenance’ means to the biopharma industry and how to measure its maturity. It showcases a tool to assess ways of working and level of digital maturity, by mapping to BioPhorum’s ‘Digital Plant Maturity Model’. It will help you and your organisation make the case for investment and justify adopting higher levels of maintenance practice, better framing the contribution of maintenance with digital maturity transition – where to build and with which capabilities. The paper articulates the value and benefits of achieving the higher digital maturity levels for smart maintenance, such as improved asset utilization and management, cost reduction and elimination of unplanned activities. The paper includes a discussion on ‘next-generation’ analytics, describing how current and future analytics packages can integrate with data solutions and the benefits they can bring to the smart maintenance approach.

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Digital plant maturity model (DPMM) version 2: A best practice guide to using the BioPhorum DPMM and assessment tool

What does the concept of ‘digital plant’ mean in biopharmaceutical manufacturing? How can it be defined, measured and transformed? What is needed to move up the maturity curve. These are all questions that a business needs to answer to establish a practical strategy to realize the opportunities that digital offers.

The biomanufacturing Digital Plant Maturity Model (DPMM) describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. Combined with the maturity assessment tool the maturity model can help IT professionals and stakeholders establish the current digital maturity of a biopharmaceutical facility and facilitates agreement on the future state, goals and strategy to get there.

This second version increases consistency by leveling scores across dimensions; simplifies the model by reducing the number of enabling dimensions; and improves its utility by resetting the vision for levels 4 and 5, aligning them with the BioPhorum Technology Roadmap.

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Digital plant maturity model (DPMM): assessment tool

What does the concept of ‘digital plant’ mean in biopharmaceutical manufacturing? How can it be defined, measured and transformed? What is needed to move up the maturity curve. All are questions that a business needs to answer to establish a practical strategy and realize the opportunities that digital offers.

The biomanufacturing Digital Plant Maturity Model (DPMM) describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. The maturity assessment tool can be used alongside the model. Using the characteristics provided for each dimension of the model, an assessment can be made of a plant or a network of plants against the five digital maturity levels against eight dimensions. The maturity model and provides the language and mechanism for having the right conversations with the right stakeholders and the Assessment Tool ensures a neutral assessment of the current state, and facilitates agreement on the future state.

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Digital plant maturity model (DPMM) v1: The development of a digital plant maturity model to aid transformation in biopharmaceutical manufacturing

Biopharmaceutical industry challenges and opportunities provided the impetus for a team of subject-matter experts to develop a biomanufacturing digital vision and a digital plant maturity model (DPMM). The white paper describes the stages of maturity from simple paper-based plants through to the fully automated and integrated ‘adaptive plant’ of the future. The business and enabling capability dimensions in the maturity model are also explained. Moreover, the paper describes the benefits of applying the DPMM such as enabling an organization to evaluate the state of its technology at all manufacturing sites, those within a network or at specific ‘sister’ sites. This evaluation can provide either a global roadmap spanning all manufacturing sites (e.g. a common gap for all IT) or a roadmap for specific sites.

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