Life Sciences companies hold themselves to a high standard when it comes to providing information to their customers. To improve outcomes and ensure the safe and proper use of medications and medical devices, companies include documents like instructions for use (IFU), Structured Product Labeling (SPL) and safety data sheets (SDS) with each product. It is vitally important to develop a strategy to manage the creation, review and approval of this information and integrate it into the packaging, labeling, documentation, and manufacturing processes.
easyDITA works with Life Sciences companies to find a better way to develop and manage documentation that complies with all regulatory requirements while improving efficiency, accuracy and time to market. We help future-proof content creation and delivery systems, enabling output to multiple channels from a single source, so patients and medical professionals can access important information on demand, in the format and language that best fits their needs.
Creating and managing the lifecycle of IFU, SPL and SDS documentation is a complex undertaking. These documents contain a mix of procedures, warnings, explanations, images, barcodes, charts and tables that are produced by many different departments in a Life Sciences organization, including research, engineering, legal, operational, documentation and training. Many rounds of review are required before publication, and a strict change control process must be followed whenever edits are proposed.
easyDITA is a complete, easy-to-use editor and content management system for the creation, maintenance and delivery of high-value information. With no software to install, authors, reviewers, subject matter experts, and translators from different departments and locations can collaborate on documents using easyDITA’s intuitive tools. The editor’s word processing-style interface is familiar and comfortable for the non-technical to use, so teams are up and running quickly with little or no training.
To eliminate the risks of non-compliance, easyDITA gives you a tool to ensure that no document is ever published without the proper review and approval. Content owners assign jobs to authors, reviewers and approvers in easyDITA’s workflow system. Reviewers go in and suggest changes and make comments directly on the content. Approvers accept or reject the changes, with no need to re-key. For compliance purposes, the system creates an audit trail of every collaboration, capturing when and why every change was suggested, accepted, or rejected, and by whom.
DITA XML is an open information standard that works by applying structure to content, breaking it down into individual topics, then giving meaning and definition to each chunk through the use of metadata tags. These modules can then be shared across product lines and linked together to create IFUs, SPLs and SDSs in easyDITA’s simple drag-and-drop interface.
Reusing modular materials from a single source repository means less duplication and less maintenance, reducing information management costs and improving accuracy. The system manages interdependencies automatically; you can see at a glance how and where your content is being used and move and rename files without breaking links and content references. There are tools for version control and branching and merging.
Finding reusable modules is fast and easy with smart search that digs deep inside content. The metadata coded into DITA tags enables patients and doctors to refine their search by narrowing the choices to a particular category or classification, and order the results based on their needs.
Life Sciences companies that source or distribute their products internationally face the additional challenge of translating content into multiple languages quickly and accurately. By managing the reuse of product content you can greatly reduce the amount of localization work. When content is revised, you only have to translate what changed, not the entire IFU or data sheet.
With a CMS like easyDITA you can automate your translation processes by exporting content to a localization solution using a standard format like XLIFF, then import translated files back into easyDITA to manage and publish. Translating each module as soon as it is ready means you can publish everywhere at the same time, dramatically reducing time to market.
In addition to multiple languages, each country has its own regulations governing the content and structure of IFUs and SPLs, and these rules are constantly evolving. With easyDITA you can create templates for each region and import the required modules at the click of a button, saving more time and money.
Even the best information is useless if it’s not available at the point of need. This is particularly true for healthcare facilities that have hundreds of medications and dozens of medical devices on their shelves. That’s an overwhelming amount of information to manage and maintain, especially if it’s stored in paper documents.
To ensure that critical patient information is always available, a good content strategy will include an electronic delivery solution. For that reason, more and more regulatory agencies are beginning to require that Life Sciences industries adopt standards that define information in an XML format so it can be freely exchanged online.
easyDITA is XML-based so it’s well-suited for this purpose. Content stored in easyDITA can be delivered anywhere, including web portals and apps. Taking advantage of systems like the FDA’s proposed unique device identifier (UDI), you can make IFUs and data sheets instantly accessible to patients and healthcare providers – right on their smartphones!
Making information dynamic
Information standards can address other challenges of a highly-regulated, global business. The DITA XML standard was built to handle technical information that includes a mix of content types: concepts, procedures and reference information (tables and figures). With an architecture that defines the right structure for each information type, easyDITA can present information in formats that are both human and machine-readable. Data can be integrated into ERP, PLM and other business systems to produce dynamic results. Content can be shown or hidden based on how it is tagged, information systems can take into account the background and context of a subject, and key processes can be automated.
Imagine a future where information about drugs and medical devices are accessed on phones and tablets (or the device itself). Using QRC codes and pulling geolocation, touch, orientation, direction and motion information directly from the smartphone, medical professionals and patients can receive personalized walkthrough instructions based on who they are, where they are, what device they are using, and what they want to do.
Interested? Join easyDITA’s Patrick Bosek and Howard Shatz of Data Conversion Laboratory (DCL) as we explore the challenges, benefits and best practices of structuring your content with the DITA XML open information standard.