Getting Started with Sofie: 4 Focus Areas for Success

A lot has happened since we first launched Sofie, so it felt like a good time to share what we've learned about getting the most out of the platform.

Over the past year, we've onboarded teams across CDMOs, A&E firms, and biotech companies. We've watched supply chain teams cut material specification generation from 5 hours to 6.5 minutes—a 97% time reduction. We've seen quality teams cut investigation report review feedback from 60 minutes to 10 minutes, an 83% improvement that accelerates root cause analysis and CAPA timelines. We've helped regulatory affairs groups complete FDA report creation 67% faster, going from 6 hours to 2 hours while reducing resubmission risk with more accurate, compliant submissions. And we've learned that the teams who see the fastest time-to-value all share a few things in common.

In this post, we’ll walk through the foundational setup that separates teams who get immediate value from Sofie from those who struggle to find their footing—and share specific examples of how our most successful users have structured their work.

Workspaces: The Foundation of Everything

Traditional document management in biopharma typically relies on systems like Veeva or SharePoint—deep, compliant repositories that serve their purpose but often become static file folders rather than practical operational tools. Sofie doesn't compete with these systems; it works alongside them, transforming your existing documentation into dynamic, intelligent assets.

Each workspace houses your chats, meetings, drafts, and files—everything Sofie needs to understand your project and deliver relevant, grounded responses.

To date, our pilot customers have built over 2,000 workspaces, and our own team has built 100+ to organize and optimize our day-to-day work. Here's how one quality team set theirs up.

For example, a quality team at one of our pilot clients needed to streamline investigation reviews—a process that previously required manually cross-referencing deviation reports, SOPs, and historical investigations to draft recommendations. They created a dedicated workspace, uploaded their investigation templates, historical deviation reports, and relevant SOPs, and started asking Sofie to help.

Now when a new deviation comes in, they ask Sofie to cross-reference historical deviations, identify patterns, and draft initial recommendations for root cause analysis. What used to take 60 minutes of manual review and synthesis now takes 10—an 83% time savings per investigation.

The key was focus. They didn't upload everything; they uploaded what mattered for that specific workflow. The more targeted your workspace, the better Sofie performs.

Our most common advice is: identify your team's single most painful information bottleneck and dedicate your first workspace exclusively to solving that specific challenge. From there, layer in context—documents, and also chats, CoDrafts, and CoMeetings. This is how Sofie moves from answering questions to understanding your project.

Your First Documents: Quality Over Quantity

Like any institutional knowledge layer, your output is only as good as your input. Sofie thrives on context-rich, high-value documents—the ones you reference daily, that drive decisions, and that your team collaborates on. Start with cleanly named, current PDFs and a logical folder structure. Focus on documents that power your workflows, not archival materials. Add incrementally as you identify gaps. The teams seeing the fastest time-to-value aren't uploading everything at once—they're curating workspaces that reflect how they actually work, then expanding from there.

CoDrafts: Collaborative Document Creation That Actually Works

Our newer CoDraft feature delivers one of the greatest efficiencies for any Sofie user. CoDraft is the best place to outline, draft, and iterate on a document when you have a large amount of information to pull in (whether it’s summarizing source documents or collaborating with teammates on precise, high-stakes content.). 

Here's how one regulatory affairs team uses it: When preparing a response to an FDA information request, they open a CoDraft and provide Sofie with the relevant guidance documents and their previous submissions. Sofie generates an initial draft, and then the team refines it collaboratively—highlighting specific sections for revision, asking Sofie to expand on technical details, or requesting alternative language for sensitive topics.

The team can verify and validate all the results by using sources to help quickly reference source documents that Sofie is pulling from–final decisions remain human-led. Then, they can export to PDF or Word to refine formatting and ensure regulatory and quality guidelines are met. CoDrafts operate within your existing security and access controls, accelerating document creation without expanding risk.

Using Sofie, a response that typically takes a full day of fragmented work across multiple team members took just a few hours of focused collaboration—and the team now has a reusable framework for future FDA requests.

CoMeetings: Turn Conversations into Context

CoMeetings make it easier to capture conversations and transform them into actionable, searchable knowledge. Sofie joins your call, captures the full transcript, and generates a structured summary—surfacing key decisions and action items so you can stay focused on the discussion itself.

For example, a project manager at one of our A&E firm pilots used to spend 30 minutes after every client call writing up notes and extracting action items. Now she simply adds Sofie to the meeting. Sofie generates the minutes, identifies decisions, and organizes follow-ups—ready to share before she's left the room.

But the real value isn't just the time savings. It's that she's fully present during the meeting itself—catching nuances in client feedback, asking better questions, and building stronger relationships instead of splitting attention between listening and documenting.

You can also integrate CoMeetings directly into your workspaces, turning isolated conversations into persistent context. When you're drafting a follow-up document or reviewing project history, Sofie can reference what was discussed—connecting decisions back to the conversations where they happened.

Our Pilot Clients are Seeing Success with Sofie, Everyday

• It's not just us—our early adopters are seeing measurable impact from using Sofie across their operations. Here are a few examples:

• A leading CDMO deployed Sofie across their Tech Ops team, where one VP reports it's "becoming my go-to tool." Their use cases include statistical calculations, contract verbiage review, budget variance analysis, and walk-across summaries. One director called it "a huge success" after Sofie read, interpreted, and summarized all 15 Quality Technical Agreements faster than they could have done manually.

• A top A&E firm streamlined workshop coordination—previously one of their most time-consuming operational tasks—into an automated workflow. Their Technical Operations Manager now saves at least 4 hours per session, redirecting that time to higher-value client work.

• Quality Assurance teams are achieving 60% near-perfect drafts in protocol document review, dramatically reducing revision cycles and accelerating timelines for validation and release.

• IT Operations cut daily user account reporting by 96%—from 7 hours to just 15 minutes—freeing up an entire day of manual work every week.

The most common advice we give customers when they ask about rolling out Sofie is that you need to do more than just provide the tool. You need to identify use cases, encourage consistent usage, and set expectations around how your team is expected to use Sofie.

If you leave these choices to chance, your team will still see some benefit from using Sofie, but it's really only when you get your entire department moving in a consistent direction that you begin to see substantial, measurable returns.

And remember, Sofie is not meant to replace your experts—it's meant to enhance them. The goal is to free your team from the repetitive, time-consuming work so they can focus on the judgment calls and strategic decisions that actually require human expertise.

Looking Ahead to 2026

Our team has shipped nearly 80 new features since July—workspaces, CoDrafts, CoMeetings, and the foundational infrastructure of Sofie. The roadmap for 2026 is even more ambitious, and we are confident Sofie will continue to help teams work smarter and faster.

Spoiler alert: If you've been waiting for AI that doesn't just assist but actually executes—agentic workflows that orchestrate complex, multi-step processes across your existing systems—things are about to get very interesting…

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