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BSI (British Standards Institution) develops standards for the international market. It helps companies apply standards to improve their services and products; supports them as they comply with certain conditions and regulations; and provides useful information and guidance to help them succeed.
BSI chose the MarkLogic Enterprise NoSQL database platform, with its integrated semantics and search, to underpin the BSI Compliance Navigator service, which launched in 2014.
BSI Compliance Navigator revolutionises the discovery, organisation and anticipation of changes affecting regulatory and compliance information and standards, customised for each new product and market. The first Compliance Navigator service is for medical device manufacturers.
BSI Compliance Navigator helps manufacturers in highly regulated markets bring products to market quicker by making it significantly easier and faster to ensure compliance around the world.
Before Compliance Navigator, many man hours were spent tracking documents that were stored randomly, using Excel spreadsheets to try to record information, and combining that body of information with related regulatory information. This resulted in very complex, protracted, difficult situations where customers were just putting up with documents that didn’t really fit their needs.
BSI set out to resolve this challenge and provide more value-add to its customers.
A big issue is that if customers don’t know the standard that they’re looking for they can spend an enormous amount of time and energy trying to find it. Making the information discoverable and accessible was the main goal.
Previously, BSI’s systems for navigating compliance were focused on document-centric creation and delivery, with processes governing the information and metadata, rather than being structured around making it available – and easy – for customers to use. It needed to make the information more discoverable, instead of being locked away in flat documents. It also had to tap into its metadata, i.e. information about the information, locked within its internal systems.
BSI recognised that it had a real opportunity to use its information to help customers get much better insight into future changes in regulation and standards so they can prepare and adapt their manufacturing processes.
BSI turned to MarkLogic to address these opportunities and take its standards information into an information-rich, web 2.0 environment.
MarkLogic was chosen because of the database platform’s ability to integrate, manage, search and link vast amounts of heterogeneous data types and workflow capabilities. BSI also takes advantage of MarkLogic’s semantic features and support for rapid application development. MarkLogic allows BSI to manage all its data then structure the information properly and introduce rapid discoverability.
The semantics technology in particular introduces taxonomical classifications to a body of information that has no classifications, enabling guided search. MarkLogic’s semantic search capability allows users to type the attributes of the medical device they are working on, “spinal cage” for example, and matches terms from the taxonomy, for example “spinal fixation systems.” Once the user has selected a taxonomy term, the application searches across the triples in order to find concepts that are related. The search results do not just return documents where the words “spinal fixation systems” are present, the search also looks to see what it can discover about spinal fixation systems.
By using MarkLogic’s semantics capability, the system uses triples to determine that a spinal fixation system is a surgically invasive, implantable medical device. Now that it knows what kind of device it is, it can find the relevant documentation for packaging, sterilisation, safety and quality assurance and so on for these types of devices, despite the fact that words “spinal fixation systems” never appear in those documents. The user is also provided with conceptually related taxonomy terms that allow them to further navigate via the taxonomy to find even more documentation.
The power of MarkLogic’s integrated search is also another valuable feature in that it does not require a user to be an expert on the documentation itself. Users do not need to understand how lawyers draft legislation or how standards bodies number their documents. The use of RDF and the GMDN taxonomy to power the search makes it accessible to the people who are working in the device manufacturing team because they can use terminology that they understand. It also ensures that documents that are related in unanticipated ways are discovered during a routine search.
Compliance Navigator also aggregates the diverse data and content required for each industry and updates it in real time, which ensures medical devices companies’ paperwork is up to date and compliant. Rather than the traditional laborious approach of having to check through standards every year when a filing is due, it is always ready to hand.
Marklogic has also enabled BSI to introduce new features that customers were clamouring for, such as comparing an old document with a new document.
Now live, Compliance Navigator is about as far away from a static document as you could possibly get. It looks like a simple workflow at the surface, allowing medical devices regulatory affairs officers or engineers to look into a ‘file cabinet’ that may be pre-classified for them according to topic matter, or they can create their own file cabinet. But underneath that surface, the discoverability component makes the service very rich and deep.
BSI has already received very positive feedback. Shirley Bailey-Wood comments, “Our customers have been amazed, I think, by the leap from hunting around for information and not being sure whether the information is complete, to having an easy-to-use tool at their fingertips.”
BSI prides itself as being at the forefront of its industry globally, in standards development, innovation and delivering value to customers. Using MarkLogic as the platform for Compliance Navigator, it has been able to raise the game competitively with a very rich and deep product.