Module 12 2019

Document Process Best Practices

Processes are extremely important in any submission Best Practice Model.

• Documents are created so that they are e-Submission Ready which means:

• Navigation is added upstream in the authoring process which reduces the need to add or correct bookmarks and hyperlinks on the critical path. • Files are formatted correctly before approval which eliminates rework and may automate the creation of certain navigation.

• Standards are utilized to reduce inconsistencies across documents and submissions.

• Functions may rely on document specialists to assist in developing e-submission ready documents.

• Technology such as document management and publishing tools are employed to streamline the submission process. • A strong partnership with IT exists to ensure the technology is configured to support efficient processes and standards.

• Companies take internal advantage of navigational (eCTD) requirements for agencies.

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