Process-focus with roles aligned to training – Simplifying documents

When organizing documents in a larger company that is highly regulated, documents must be written based on process and not function.

Write from general to specific and only based on purpose or specific process. Create roles that are aligned to training and not constrained by changes in the corporate structure.

There must be one high-level SOP for each process and categorize documents belonging to one SOP as cross-functional or functional work instructions, templates/forms and enabling documents (manual or checklist).  You do not need to hire 10 project managers.  Each member of the process must have a process owner, SMEs and a technical writer.

Communicate results regularly/daily/weekly. Allow sufficient time to reformat and categorize or scope all existing documents to future state documents.

Some SMEs are reluctant to leave behind details which can be documented in enabling documents such as checklists, manuals and guides.

Each high-level process-focus SOP must have a hierarchy of documents pointing to it.

You may use SharePoint to collaborate and manage these documents before you store and formalize them using Veeva Vault.

The key is that management drives this process focus document simplification without over staffing or under staffing and in conjunction with other process improvements.