Advantages of DITA for the Life Sciences
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This 60-minute webinar will explore the challenges, benefits and best practices of structuring your content with the DITA XML open information standard: Efficient - Reuse content between IFUs, catalogs and data sheets Responsive - Generate output in multiple formats and languages Consistent - Create compliant documentation in a single source system
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Advantages of DITA for the Life Sciences
- 1. Advantages of DITA for the Life Sciences Howard Shatz, DCL Patrick Bosek, easyDITA October 30, 2014
- 2. Valuable Content Transformed • Document Digitization • XML and HTML Conversion • eBook Production • Hosted Solutions • Big Data Automation • Conversion Management • Editorial Services • Harmonizer
- 3. Experience the DCL Difference DCL blends years of conversion experience with cutting-edge technology and the infrastructure to make the process easy and efficient. • World-Class Services • Leading-Edge Technology • Unparalleled Infrastructure • US-Based Management • Complex-Content Expertise • 24/7 Online Project Tracking • Automated Quality Control • Global Capabilities
- 4. We Serve a Very Broad Client Base . . .
- 5. . . . Spanning All Industries • Aerospace • Associations • Defense • Distribution • Education • Financial • Government • Libraries • Life Sciences • Manufacturing • Medical • Museums • Periodicals • Professional • Publishing • Reference • Research • Societies • Software • STM • Technology • Telecommunications • Universities • Utilities
- 6. Our Presenters • Howard Shatz, DCL’s SPL Project Manager, since 1991. • Active in SPL since its development began in 2003. • Active member of the SPL Working Group composed of pharmaceutical companies and conversion vendors. • Frequent contributor to the SPL Working Group Wiki discussion forum. • He serves on the Process Communications, Establishment Registration/Drug Listing, and OTC subteams. • He has a BS in Computer Science from New York University. Prior to joining DCL, Howard was an account manager at EDS.
- 7. Our Presenters • Patrick Bosek, Founding Partner, Jorsek LLC (easyDITA). • Key focus areas: Improving authoring processes and improving the entire information supply chain from content creation to consumption • 10 years experience in publishing systems and content management • Deep understanding of XML, semantic content, DITA
- 8. Best Practices for Pre-Conversion Authoring • Use paragraph styles for special paragraphs, such as titles and captions • Use character styles for special text, intended to be tagged with content tagging, such as uicontrol • Write tasks as an ordered list, not as a table. • Write admonitions (notes, cautions, warnings, etc.) as paragraphs of text, not tables • Cross reference only to specific headings, tables, figures, steps, etc., not page numbers • Limit tasks to have only two levels of steps, the third and lower levels will have to become lists in DITA
- 9. Best Practices for Pre-Conversion Authoring • Use paragraph styles for special paragraphs, such as titles and captions • Eliminates need to guess what purpose of paragraph was, such as figure title or section title • Serves as map to DITA tagging
- 10. Best Practices for Pre-Conversion Authoring • Use character styles for special text, intended to be tagged with content tagging, such as uicontrol • Distinguishes between text that is italicized or bolded for emphasis and text that has special meaning, such as user input. • Serves as map to DITA tagging
- 11. Write tasks as an ordered list, not as a table. Example 1. Step Action 1 Check the phase sequence in the mains with with the phase sequence indicator. 2 Check the direction of rotation of impeller. If a If a dry installation is made, check the direction of rotation through the inlet elbow access cover.
- 12. Write tasks as an ordered list, not as a table. Step Question If no... If yes... 1 Is an alarm signal indicated on Example 2. on the control panel? go to step 2. check that the impeller rotates freely. check if the FLS indicator indicates alarm. check that the overload protection is reset. check the termistor/thermal contact. Comment: If it is out of order, contact contact an XXXX shop. 2 Can the pump be started manually? go to step 3. check the start level regulator. Comment: clean or replace. check that the thermal contacts contacts have not opened. check that all connections are intact. check relay and contactor coils. coils. check that the control switch (Man/Auto) makes contact in both positions. Example 2.
- 13. Write admonitions (notes, cautions, warnings, etc.) as paragraphs of text, not tables Note: This is an example of a note note inside a table. This would be better handled in the input file as textual note: Note: This is an example of a note inside a table.
- 14. Cross reference only to specific headings, tables, figures, steps, etc., not just page numbers • For example in the text you may have something like: Lost or forgotten password – Browse to the location of the private recovery key used for the project. (See page 121 for information about creating a recovery key.) Enter the password for the private part of the recovery key. Enter and confirm a temporary password for the user. You must communicate this temporary password to the user separately.
- 15. Cross reference only to specific headings, tables, figures, steps, etc., not just page numbers • Where on page 121 you’d find an untitled task like below: • To set a recovery key: You can specify the key to be used for access to encrypted ACE instances. If you specify password protection for an ACE master and want to be able to reset the password for a deployed ACE instance from that master, you must specify a recovery key before you create the package that includes the virtual machine. a. Click Set recovery key. The Recovery Key dialog box appears. b. In the Recovery Key dialog box, select Use recovery key to configure a recovery key. c. To use an existing PEM format key pair, click Browse for Existing Key to navigate to the public key of the pair you want to use. To create a new Above case would be better handled if task on page 121 were titled, and referenced by a title rather than just page number.
- 16. Limit tasks to have only two levels of steps, the third and lower levels will have to become lists in DITA 1. See instructions below. 2. Install the Hex Coupler Guard as follows: a. Spread the inner guard and place it over the coupler. b. With the inner guard straddling the support bracket, install a cap screw through the hole in the support bracket and guard located closest to the pump. Do not tighten the capscrew. c. Spread the outer guard and place it over the inner guard. d. Install the outer guard cap screws by following the step stated below which pertains to your particular pump: • For pumps with a motor saddle support bracket: Ensure the outer guard is straddling the support arm, and install but do not tighten the two remaining cap screws. • For pumps without a motor saddle support bracket: Insert the spacer washer between the holes located closest to the motor in the outer guard, and install but do not tighten the two remaining cap screws. e. Position the outer guard so it is centered around the shaft, and so there is less than a 1/4" of shaft exposed. f. Holding the guard in this position, tighten the three cap screws. 3. Close the cover
- 17. Documentation Challenges • Complex documents • Highly structured IFU, SPL, and data sheets • Mix of procedures, warnings, explanations, images, and tables • Diverse authors • Research, engineering, legal, operational, documentation and training • Complex lifecycle • Many rounds of review: Strict control processes • Many outputs: packaging, labeling, documentation
- 18. Need: Access to information • Single source • Enterprise-wide access to vital business information • Web-based is best, especially for global • Secure • Permissions-based read/write access
- 19. Need: Collaborative authoring tools • Simple authoring tools • Easy-to-use for diverse content contributors • Up and running quickly with little or no training • Templates • Ensures IFUs, SPLs, have consistent structure
- 20. Need: Complex document assembly • Single sourcing • Less duplication, less maintenance • Increased accuracy, consistency • Modularity • Need to manage interdependencies • Link maintenance
- 21. Need: Collaborative review • Review and approval workflow tools • Easy-to-use for diverse content contributors • Audit trail of every collaboration • Version control • Branching and merging • Integrate with quality system
- 22. Need: Multichannel delivery • Electronic delivery • XML-based • Online access, Web portals • Integrate with ERP, PLM, CRM systems • Future-proof • Mobile delivery • Enables compliance with future regulations
- 23. Need: Localization • Quick, accurate translations • Reduce amount of translation work with reuse • Modularity – only translate what changed • Automate process • Import/Export content to a localization provider • Standard format – XLIFF • Templates for each location, regulatory body
- 24. Need: Findability, usability • Intelligent search • Refine searches by filtering choices - attributes • Order results based on context – metadata, keywords • Support for structured information • Machine-readable data elements • Supports industry-defined schemas
- 25. Q&A Howard Shatz (718) 307-5719 hshatz@dclab.com Patrick Bosek (877) 492-2960 patrick.bosek@easydita.com
Editor's Notes
- -there’s a lot more components to getting a conversion project done than most people think -and there’s a lot more things that need to be setup so that there’s no surprise, or rework, later when you’re chunking things out -I tried to lay out the common tasks that I would expect in a large conversion project – there are of course some variations – but these are the major ones -traditionally most of this was done by whoever was “in charge of the conversion” – and that’ was the predominant model until a few years ago. -what we’re finding today is that many times a hybrid model – where different parties handle some of the task might work better, especially when the client company already has significant resources for some of the tasks, but needs expertise for others -later in this talk I will discuss several case studies of how this might work -but first, I would like to through what the various steps are, and a little about what gets done in which one -these two wheels represent the various tasks – the left wheel, read clockwise, represents what gets done to get set up, and the right wheel represents the production tasks.
- -there’s a lot more components to getting a conversion project done than most people think -and there’s a lot more things that need to be setup so that there’s no surprise, or rework, later when you’re chunking things out -I tried to lay out the common tasks that I would expect in a large conversion project – there are of course some variations – but these are the major ones -traditionally most of this was done by whoever was “in charge of the conversion” – and that’ was the predominant model until a few years ago. -what we’re finding today is that many times a hybrid model – where different parties handle some of the task might work better, especially when the client company already has significant resources for some of the tasks, but needs expertise for others -later in this talk I will discuss several case studies of how this might work -but first, I would like to through what the various steps are, and a little about what gets done in which one -these two wheels represent the various tasks – the left wheel, read clockwise, represents what gets done to get set up, and the right wheel represents the production tasks.
- -there’s a lot more components to getting a conversion project done than most people think -and there’s a lot more things that need to be setup so that there’s no surprise, or rework, later when you’re chunking things out -I tried to lay out the common tasks that I would expect in a large conversion project – there are of course some variations – but these are the major ones -traditionally most of this was done by whoever was “in charge of the conversion” – and that’ was the predominant model until a few years ago. -what we’re finding today is that many times a hybrid model – where different parties handle some of the task might work better, especially when the client company already has significant resources for some of the tasks, but needs expertise for others -later in this talk I will discuss several case studies of how this might work -but first, I would like to through what the various steps are, and a little about what gets done in which one -these two wheels represent the various tasks – the left wheel, read clockwise, represents what gets done to get set up, and the right wheel represents the production tasks.
- -there’s a lot more components to getting a conversion project done than most people think -and there’s a lot more things that need to be setup so that there’s no surprise, or rework, later when you’re chunking things out -I tried to lay out the common tasks that I would expect in a large conversion project – there are of course some variations – but these are the major ones -traditionally most of this was done by whoever was “in charge of the conversion” – and that’ was the predominant model until a few years ago. -what we’re finding today is that many times a hybrid model – where different parties handle some of the task might work better, especially when the client company already has significant resources for some of the tasks, but needs expertise for others -later in this talk I will discuss several case studies of how this might work -but first, I would like to through what the various steps are, and a little about what gets done in which one -these two wheels represent the various tasks – the left wheel, read clockwise, represents what gets done to get set up, and the right wheel represents the production tasks.
- Instructions for use (IFU), Structured Product Labeling (SPL) and safety data sheets (SDS) improve outcomes and ensure the safe and proper use of medications and medical devices Life sciences companies need to develop and manage documentation that complies with all regulatory requirements while improving efficiency, accuracy and time to market.
- 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.
- 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.
- Opportunities for reuse - Share modular content between products and deliverables 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.
- 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.
- 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!
- 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.
- 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. 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. 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.