Solutions · Engineering & Consulting
Deliver more client workwith the same bench.
Sofie drafts the validation, facility and quality deliverables your consultants produce, in each client's format, so senior people spend their hours on judgment rather than assembly.
Tech Transfer Charter · Controlled
LB-204 Drug Substance Transfer
Version 0.4 · Draft for QA review
3. Scope of Transfer
This charter governs the transfer of the LB-204 upstream and downstream process from Larkspur Biologics, Cambridge (sending site) to {Receiving site} (receiving site). The transfer covers the 2,000 L fed-batch process through drug substance release, including fill-finish operations.
4. Roles and Responsibilities
5. Process Overview
CoDraft: deliverables drafted in your client's own Word format, exported exactly as they appear.
Inconsulting,thehoursarethebusiness.Sofietakesthehoursspentassemblingdeliverablesandreturnsthemtotheworkclientsactuallypayfor.
Work Sofie takes on
Work Sofie takes on for engineering and consulting firms
Deliverable-heavy workflows from CQV, quality and operations.
01
User Requirements Specification (URS)
CQV · Workflow
Turn your system needs and design inputs into a traceable, qualification-ready URS — in an afternoon, not weeks.
Manual effort today
20–40 hours across engineering, QA, and validation
02
Validation Master Plan (VMP)
CQV · Workflow
Turn scattered equipment lists, half-finished qualification records and undocumented intent into a governing Validation Master Plan — scoped, risk-prioritised, and honest about what is not yet covered.
Configured to your procedures
03
Computer System Validation (CSV / CSA)
CQV · Workflow
Turn scattered requirements, risk assessments, vendor documentation and test evidence into a GAMP 5-aligned validation deliverable — drafted, traced end to end, and gap-checked in an afternoon rather than a month.
Manual effort today
Three to six weeks per system
04
GMP Facility Proposal / Design Basis
Business Operations · Workflow
Turn your process and site inputs into a design-basis-grade facility document — in an afternoon, not weeks.
Manual effort today
30+ hours across engineering, QA, and EHS
05
Quality Risk Assessment (QRM / FMEA, ICH Q9)
Quality Records · Workflow
Turn a process, change, or deviation into a structured ICH Q9 risk assessment — hazards scored, ranked, and ready to act on — in an afternoon, not weeks.
Manual effort today
15–30 hours across SMEs
06
Knowledge Gap Assessment
Tech Transfer · Workflow
Authors, or independently reviews, a GMP-compliant Knowledge Gap Assessment for a defined product/process/site-pair technology transfer scope.
Estimated time saved
~15–25 hrs per knowledge gap assessment
07
Statement of Work (SOW)
Business Development · Workflow
Turn your engagement notes and service offering into a tightly scoped SOW — in an afternoon, not weeks.
Manual effort today
10–20 hours drafting and negotiating scope across BD and delivery
08
Lessons-Learned / After-Action Report
Business Operations · Workflow
Turn a closeout or a post-event review into a record where every lesson names what should change, where that change lives, who owns it, and how you would know it had been adopted.
Configured to your procedures
A day in the life
The same work, without the assembly.
Your experts still make every call. Sofie gathers the evidence, drafts in your format and marks what is missing.
A new engagement
Scope written tightly the first time
- Before
- The SOW goes back and forth because the boundary and assumptions were never pinned down.
- With Sofie
- Sofie drafts the SOW from the proposal and discovery notes and lists the assumptions to confirm with the client.
Deliverable week
Client formats, handled
- Before
- Consultants rebuild each deliverable in the client's template and fix formatting by hand.
- With Sofie
- Import the client's .docx as a template; Sofie fills it from the engagement workspace and the export matches Word exactly.
Close-out
Lessons that carry to the next client
- Before
- What the team learned stays with the people who were on the project.
- With Sofie
- Sofie drafts the after-action report from the engagement record, and Memory carries the lessons forward under your governance.
The platform behind it
Part of one connected platform
CoDraft
Word-faithful documents Sofie drafts, redlines and cites with your team.
Templates
139 prebuilt templates, and your own formats, filled with sources attached.
Workspaces
Every program, site and client, with its files, people and history in one place.
Memory
Institutional context that carries forward, under your governance.
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.