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Knowledge management: User requirements specification for a knowledge management system for use in a biopharmaceutical setting

1 May 2020
Advanced Therapy Medicinal Products
Development Group
Drug Substance
Fill Finish
Information Technology
Supply Chain to Patient
Supply Partner
Sustainability
Technology Strategy
Knowledge management: User requirements specification for a knowledge management system for use in a biopharmaceutical setting
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This User requirements specification (URS) document will provide a starting point for the biopharmaceutical industry to build true knowledge management (KM) capability. It is intended to help solutions providers innovate in the area of relevant tools and systems by providing guidance on the specific needs of operating companies. The design, implementation and maintenance of a comprehensive KM platform, solution or system is a complicated undertaking — this is because it should ultimately span many functions, disciplines, business processes and all products over their respective lifecycles. To be effective, a KM capability must also address all the components of an enterprise: people, process, content and technology. The biopharmaceutical industry has been slow to adopt KM practices largely because of this multi-dimensional challenge combined with the inherent complexity of biopharmaceuticals, including therapeutic effect, product chemistry and manufacturing technologies.

Many IT systems allow information capture, storage and retrieval. And with the advent of advanced analytics and ‘big data’, more and more data can now be connected. However, the way data is transformed into information and then knowledge requires careful consideration.

This is why the BioPhorum Knowledge Management Workstream has published a User requirements specification for a knowledge management system for use in a biopharmaceutical setting to help support an organization’s knowledge management activity in any technology procurement. While the paper is organisation and technology agnostic, it does provide a detailed list of questions to ask when approaching procurement or developing IT applications to deliver knowledge management goals.

The paper takes organizations back to the purpose of knowledge management, asks them to think about how technology will improve this, and then provides the starting point for a more detailed specification based on how user roles will want to interact with the data.

All these actions will significantly improve the outcomes of technology application in terms of business benefit, meeting systems’ acceptance criteria, reducing waste in a project and, ultimately, lowering costs.

Many knowledge management systems are bespoke and focus on specific areas of business (such as product development, quality assurance or regulatory compliance), and are developed by individual departments as opposed to taking an enterprise wide view. However, because of organizational silos, this means learning and best practice is often not shared, so this paper aims to fill this gap and help projects avoid common pitfalls.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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