Case Study: Design Control Templates

Simplify the process of creating DHF documents and improve their thoroughness and consistency.

Develop a set of structured, self-tutoring templates for all DHF document types, suitable for either manual or electronic signature. Instructions, which do not print, are placed throughout the templates, just prior to each section where they can be easily referenced. Detailed section and subsection headings prompt the user to consider all relevant elements for that document type. Examples of standard "boilerplate" text are included where appropriate to use, edit, or delete as desired. A built-in special toolbar is also included to make formatting easy. keeping documents consistent regardless of author.

These templates are in use at a number of companies, helping to create high quality DHFs.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control