Module 12 2019
Document Process Best Practices
Define tasks, roles and responsibilities to support e-Submission Ready standards
● What does the author do? ● What do the formatters do? ● Who reviews what at each step?
Ensure an appropriate, early team review of documents includes a formatting check
● Confirms consistent use of templates and authoring tools/standards
● Addresses formatting considerations early in document development
● Establishes focus toward submission ready standards for content and format
Benefits
● Improves delivery of submission ready documents ● Establishes global consistency ● Reduces re-work potential
The Organisation for Professionals in Regulatory Affairs
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