We have transformed the technical document production process, offering a valuable alternative to the traditional approach of Microsoft Word™ and Excel™:

• Generate tables and charts directly from data
  
• Assemble document map structure with reusable topics
  
• Eliminate manual verification of data
  

What are the challenges that we are trying to solve?

• Creation of complex, technical documents with hundreds of sections, tables, and images
  
• Data from multiple sources
• Significant time devoted to data transcription and manual verification
  
• Costly effort performed by valuable resources – e.g. data scientists
  
• Collaboration with multiple team members
  
• Submission to regulatory agencies
• High document rejection rates
  

What is the value?

• Reduce submission time
  • Eliminate manual data verification
  • Reuse common content
    
• Reduce cost
  • Reduce scientist effort and cost on content authoring
• Improve Right First Time
  • Increased accuracy with reused, released topics
    

What industries are we targeting?

• Initially in Life Sciences, particularly BioPharma
  • IPE: CMC Content Authoring
    
• Where else could we add value?
  • A&D: flight manuals, airworthiness certification
  • T&M: product manuals, operation or repair documentation
  • IE: technical manuals
    

How does it work?

With Structured Document Manager, we are proposing a new way of working:

1. Connection and visualization of your data sources

• Connect to all the data sources (e.g. LIMS, MES…) and consolidate them in a single place
  
• Once you can visualize all the data into categories (for example which test, which condition…), filter for the data of interest
  

2. Automated generation of a structured and reusable content element (topic)

• Select the data to generate the desired table or chart
  
• Refine your search to include or exclude certain data
  
• The imported data is traceable and the verification is easier
  

3. Update & release the reusable content element

• The generated table is imported into a topic element that can be edited, reviewed, and released
  
• A topic can be text, table, image, graph…
  

4. Reuse of released content elements in multiple reports without additional verification

• Content elements can be reused in several documents
  
• Once the content element is Released, it will be released in every document where it is used; therefore, numerous data verification steps are eliminated
  
• Output to PDF, HTML
  

When will it be available?

• The role XDO was released on 2022x FD01 in CA to control distribution
  
• It is planned to be available in GA on 2022x FD04
  
• Cloud only
  

Will XDO replace QUC or QUMAS?

No. Structured Document Manager focuses on content creation; therefore, it is a complement to these applications, rather than a replacement.

Do you want to know more?

We will go deeper in an upcoming post. In the meantime, feel free to enter your questions below.

Figure 1 - Structured Document layout