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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