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.