How Sofie Transforms Document Creation with CoDraft

In biopharma workflows, drafting isn’t confined to a single platform or point in time. It’s an iterative and collaborative process that happens across tools, teammates, and stages of thought. Whether you’re building out batch records, revising regulatory submissions, or editing existing tech transfer protocols, the more you can streamline data gathering and edits, the more effective and efficient the drafting process will be.

That’s why Sofie’s newest capability, CoDraft, was built to meet you where you work – accessible alongside chat in Sofie so you can leverage Sofie’s institutional knowledge and collaborate with your project team. We know how much time you spend bouncing between Word versions, tracking down edits in email chains, and sifting through versions in Veeva or Sharepoint.

How Sofie Supports Drafting, However Your Work

There are two unique ways to draft any way you want with Sofie, supporting your end-to-end document workflow:

• Working with Sofie: Our in-app draft editor, CoDraft, makes it easy to generate content, get answers, and build drafts of documents in whole or section by section. Chat naturally to collaborate with Sofie to refine and iterate on your document. With Sofie Magic, formatting, revision, and semantic capabilities, you can focus on polishing specific sections of your document within Sofie, then export your structured document to Word, PDF, or copy content to a Google doc when you're ready.

• Collaborative Editing: Leverage the power of CoDraft across your whole team to enhance the collaborative editing process. You can edit and refine your draft with Sofie and your teammates in real-time. It's possible for multiple team members to edit simultaneously, add comments, and track revisions as your document evolves. With full version history, formatting controls, and complete audit trails, CoDraft keeps everyone aligned from first draft to final approval—without compromising regulatory requirements.

Let's dig deeper into exactly how Sofie can empower you while drafting documents.

Drafting from the Ground Up with CoDraft

With CoDraft, you can create any document—from quick summaries to complex regulatory submissions. The possibilities are vast: create drafts from scratch, ask follow-up questions about your draft, make edits to your draft directly from the chat, create drafts from workspace files, and make your own tweaks.

To start drafting, simply ask Sofie to create a CoDraft. Say "draft a tech transfer protocol" or "create a deviation report," and Sofie opens a collaborative editor instantly. You have complete flexibility on how documents get structured and what gets included. Each CoDraft gives you a real-time editing environment where you, your teammates, and Sofie work side-by-side.

Sofie at Work: Using CoDraft to Build from Scratch

To start drafting, upload any reference documents to your workspace that you want Sofie to consider. For example, if you're looking to generate a deviation report, you might upload the relevant batch records, your deviation report template, and any related investigation notes along with your prompt.

Sofie then produces a complete first draft, and you can click anywhere on the preview to open CoDraft. From there, you can write direct revisions to the draft, get further assistance from Sofie by asking a query in chat, or highlight text and use Sofie Magic to make edits to that section.

At TransferAI, our own team is already finding value in using Sofie to build our drafts of documents whether it’s a first draft or iterations. Our pilot clients are finding the same successes with one pilot benefiting from 60% perfect drafts in protocol document review.

Edit Existing Documents with CoDraft in Sofie

It's been found that biopharma professionals spend up to 40% of their time strictly on documentation—whether it's Word, Veeva, or SharePoint, every day work revolves around documents and revisions. That's why we built CoDraft right alongside chat, so you can ask questions about your document, prompt Sofie for more details, check regulatory alignment, and refine your content without breaking your workflow.

Sofie Magic lets you revise snippets of your documents with Sofie's help—for when you really want to finetune a detail, tighten language, formalize tone, or brainstorm one specific thought. You can highlight any section and describe the changes you need in natural language, and Sofie will suggest edits you can review and accept inline.

Sofie at Work: Reviewing and Editing an SOP in CoDraft

Let’s look at a specific example. Say you need to update an SOP to reflect a new equipment qualification. You can first ask Sofie, “Review the current SOP along with the new equipment specs and validation summary.” With this prompt, attach the current SOP along with the new equipment specs and validation summary.

Sofie analyzes your document in context, and pulls it directly into CoDraft to begin editing. Sofie suggests clarifying the review objective (e.g., update vs. risk assessment), mapping the new equipment specs and validation ranges against current SOP parameters, and then drafting specific SOP redlines plus a brief impact assessment you can drop straight into change control. You can then prompt Sofie to “add a safety precaution for the nitrogen purge step.” Sofie will make these changes to your draft, you can tweak where you see fit, or continue iterating with Sofie to refine your document.

Powerful Context for Complete Documents Across the Board

Unlike standalone word processors that sit in isolation, CoDraft operates inside Sofie’s knowledge fabric—linking every draft to your workspace documents, regulatory standards, and project history. When you’re writing a deviation report, Sofie automatically brings in batch data, similar past deviations, relevant SOPs, and prior root cause analyses. The result is not just a clean document, but a defensible, inspection-ready narrative grounded in your actual institutional record.

CoDraft spans your entire technical documentation landscape:

• Regulatory Submissions: Draft CMC sections, regulatory justifications, and response letters with built-in compliance awareness

• Manufacturing Documentation: Create batch records, deviation reports, and process validation protocols

• Tech Transfer: Generate transfer protocols, equipment qualifications, and site comparison documents

• Quality Systems: Write SOPs, CAPAs, and change control documentation with consistent formatting

If you want a fresh set of high-impact ideas tailored to your use of Sofie, request a 1:1.