Templates
Your standards,filled in.
Start from 139 prebuilt biopharma templates, from tech transfer charters to CTD Module 3, or import your own. Sofie fills each field from your sources and records where every value came from.
Tech Transfer Charter
44 fields
Process Validation Protocol
43 fields
Fields
34 of 44 filledTech Transfer Charter
LB-204 Drug Substance Transfer
1. Purpose and Scope
This charter governs the transfer of {Product} from {Sending site} to {Receiving site}. The process runs at {Process scale}.
2. Validation Approach
Process performance qualification will comprise {PPQ lots}, beginning {Target PPQ start}. Intermediate hold times are supported by {Hold-time support}.
3. Roles and Responsibilities
The gallery
139 templates, about 26 fields each.
Plans, protocols, reports, records and submissions, structured so every section maps to a field Sofie can fill and a reviewer can trace.
Your own formats
The template your QMS approved, not a lookalike.
Most teams already have controlled templates. Sofie works with them as they are, so the output drops into your document system without reformatting.
Import your own .docx
Bring the controlled template your QMS already approved. Mark its fields and conditional sections, and Sofie fills it in without changing the format.
A source on every field
Each filled value records where it came from, with the citation kept, so a reviewer can check the basis for every entry.
Fill it yourself or with Sofie
Complete fields by hand, ask Sofie to fill them from the workspace, or run an orchestration that ends in a filled template.
Versions, lineage and visibility
Templates are versioned with their lineage recorded, and can be private, shared with a workspace or published across the organization.
Meeting summaries
Eight meeting templates, one for each kind of conversation.
A vendor call and an inspection prep session need different notes. CoMeeting writes each summary with the template for the meeting you held, and you can share it or carry it into the next piece of work.
- 01Standard
- 02Client / Customer
- 03Internal Project Update
- 04Tech Transfer
- 05Quality Review
- 06Regulatory Strategy
- 07Audit / Inspection Prep
- 08Vendor / Supplier
Start with one workflow.
Measure it. Then expand.
In a working session we choose a priority workflow, define your standards and review points, and agree how to measure speed, quality and capacity. Then you evaluate Sofie's work before deciding whether to expand.