LABORATORY INFORMATICS GUIDE 2016 | DOCUMENT MANAGEMENT
BANKING ON INFORMATION I
Sophia Ktori investigates how organisations can access all the data, documentation, and knowledge they are producing, while keeping commercial secrets secure
n any R&D environment, the efficient and effective collection, management, and dissemination of data are vital for
the derivation of knowledge. And knowledge is, after all, what drives research through into development, and ultimately to market. In fact, the true value of an organisation lies not so much in its products, but more in this wealth of accumulated IP, knowledge, and data, suggested Daniela Jansen, product marketing manager at Biovia: ‘Information needs to be protected, but remain accessible and, critically, usable and reusable.’ Achieving these requirements can be
tricky because, understandably, information and knowledge are scattered throughout an organisation, at different levels, and in many different formats. This leads to problems of access, searchability, and analysis, which are bemoaned by any organisation involved in R&D, and particularly in the life science sector, she continued: ‘You have to combine data accumulated through basic research, methodological and procedural information, with the results from instrumentation, and from legal and regulatory data and documentation, inventory and budget reports, and scientists’ observations and their tacit knowledge that stems from experience. Managing that breadth and complexity of structured and unstructured knowledge and output in different data formats creates huge problems at the technical level, but also from the perspective of knowledge ownership and the timely and secure provision of its access to colleagues, collaborators,
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decision makers, legal departments, and regulatory bodies.’
DIFFERENTIAL UTILISATION How an organisation or department perceives the management of knowledge and documentation depends very much on what they want to do with it, Jansen stressed. ‘In the life sciences sector, for example, knowledge is utilised very differently at different stages of a product life cycle, from ideation and early research, through to formal development, regulatory submission, approval, manufacturing, and marketing. In the regulated space, particularly, you need to have validated tools for producing documentation, whereas for the R&D sector you need tools that can also manage unstructured knowledge, data, and the resulting documentation in a far more flexible manner. Documentation also needs to have bidirectional functionality. Sometimes you want to get data out of your documents, and sometimes you want to generate documents out of your data.’
MANAGED ACCESS AND SEARCHABILITY The effective provision of managed access to documents and accumulated knowledge, and the ability to search and mine that knowledge to derive decision-making value from it, are commonly among the top requirements requested by clients, as Tim Hoctor, VP of Life Science Solutions Services at Elsevier, pointed out: ‘We work largely with the pharmaceutical and agbio industries, as well as with academia and tangential industries, such as the chemicals
sector. In life sciences R&D, in particular, the concept of knowledge and documents spans that which is generated in house, along with the wealth of information and documentation that is brought in from external sources, such as the scientific journals and other documentation in the public domain, as well as from collaborators, service providers, and licensed IP.’ From the scientist’s perspective, the main
priority is the ability to access, search, and use all that data and documentation – without having to look too hard for it. The librarian or information management department will have a slightly different perspective, Hoctor stressed. ‘They want solutions that provide the capabilities that the scientists are asking for, but they also need to control costs, and to layer on top of those search and utilisation requirements additional management considerations such as copyright, duplication of acquisition, and assignation of rights to use.’
DELIVERING DATA These are huge issues, which are compounded when considering how many different sources there are from which documentation and knowledge may be collected. ‘The scientific publishing field represents a massive conduit for getting research out into the community,’ Hoctor noted. ‘When you combine that wealth of information with the mass of documentation that is generated in-house, or by partners, collaborators, licensees, etc., the enormity of the task of identifying, collecting, collating – and delivering to relevant personnel – requisite
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