As the maturity of digital manufacturing plants increases, so does the risk of a cybersecurity or other digital incident. A successful phishing attack, for example, could adversely impact manufacturing operations and potentially take a facility offline for hours, days or even longer. A company’s ability to minimize the risk of a digital disaster in its manufacturing plants, and quickly restore operations if one occurs, is a vital area for investment to ensure delivery of drug products to patients. To do this, biopharmaceutical manufacturers must understand the cyber resilience at their differing plants and how each site fits into the context of their overall business.
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Jul 2019 | Drug Substance
The Human Performance Assessment (HPA) tool is designed to enable a biopharmaceutical organization to assess its maturity in implementing a human performance operating philosophy, as well as plan next steps toward the biopharmaceutical blue-sky for human performance. The maturity profile describes a number of stages towards blue-sky performance in seven dimensions, each containing multiple lever attributes.
This members only pack contains the, Human Performance Assessment too, a facilitator’s guide to running the assessment and a full set of blinded member industry assessment results covering 2014, 15, 16, 17 and 19 when the overall score for existing companies moved from a level of understanding to one of competence. The workstream goal of reaching competence by 2020 was reached in a year early
Aug 2018 | Drug Substance
This members only toolkit provides all the guidance, tools, assessments and case studies from across the industry to enable a site or biopharma corporation to implement the best human performance best practices. Developed through the collaboration of more than 20 corporations, the efforts of innumerable practitioners, over more that six years. This body of work, that grew from benchmarking established practices in the nuclear and aerospace industries. Going deeper and wider then published guides. This material has enabled member companies to realise reductions in deviations, growth in real capacity and reductions in lead-times from improve right first time rates in operations.
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.
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.
Data integrity (DI): Universal data integrity system assessment template in the biopharmaceutical industry
Jun 2018 | Information Technology
The subject matter experts of the BioPhorum IT Compliance Team developed this template in response to the need to ensure compliance with the regulatory guidance for data integrity demanded in the industry. The template was developed to assess the health of computerized systems and their electronic records from a data integrity perspective. Furthermore, it can be used to evaluate potential risks to a computerized system and its electronic records throughout the system’s lifecycle. An assessment may be conducted during requirements gathering as a part of the initial validation, during assessment of system changes, during periodic reviews and/or at the time of decommissioning. The assessment template should be fully developed in conjunction with a standard operating procedure (SOP) to manage consistent implementation and use. Since this is an example template it is not an exhaustive list of questions and should be augmented to meet each company’s specific needs. The template accompanies the “Data Integrity for IT in the Biopharmaceutical Industry” paper, which was developed in parallel to provide an industry response to regulatory guidelines highlighting risks, controls and best practices.