Customer: FDA-regulated medical device manufacturer

Our customer needs to improve their entire content development process. We did extensive analysis work to determine the scope of the new system. This included the following activities:

• Performed a multi-departmental information gathering effort for documentation processes, tools, and needs.
• Built a comprehensive, multi-site, cross-departmental model of current documentation processes, tools, outputs, information structures, and issues.
• Developed a broad set of requirements for documentation process and tool improvements to address additional regulatory requirements.
• Developed a multi-phased solution proposal that included:
  • Phased system architecture
  • Phased workflow diagrams
  • Information structure proposal
  • Specific tools requirements
  • Initial tools screening
  • Documentation conversion requirements and proposals
  • Annualized estimates for training, implementation, and maintenance costs

Our recommendation included system relationship, business processes, and tool functionality for document editing, content management, change management, content rendering, review management, portal presentation, and business quality processes. This is an ongoing project that will include RFP development, tool selection, tool implementation, process and tool training, and large-scale document conversion.