Solutions · Quality
Quality records,drafted from the evidence.
Sofie assembles deviations, CAPAs, change controls and product quality reviews from your batch records, logs and procedures, cites every source, and leaves the judgment to your quality team.
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: Sofie drafts and redlines alongside your team, in your Word format, with sources attached.
Qualityworkismostlyassembly:pullingrecords,retypingtimelines,checkingtheregulationagain.Sofiedoestheassemblysoyourreviewersspendtheirtimeonthedecision.
Work Sofie takes on
Quality work Sofie takes on
Prebuilt workflows from the Workflow Library, each configurable to your procedures and templates.
01
Deviation Investigation & CAPA
Quality Records · Workflow
Turn the event evidence — batch records, lab and OOS data, deviation logs, and governing SOPs — into an inspection-ready deviation investigation and CAPA plan: problem statement, timeline, evidence-bound root cause, SISPQ/product-impact assessment, and a CAPA plan, drafted and reconciled for QA review in an afternoon, not weeks.
Manual effort today
Days to weeks across QA and the investigation owner
02
Change Control
Quality Records · Workflow
Turn a change request and whatever evidence you already have into an inspection-ready change control record — impact assessed across every system the change touches, classified against your own matrix, and reportability called — drafted and reconciled in an afternoon.
Manual effort today
Two to three weeks of meetings
03
Product Quality Review (APR/PQR)
Quality Records · Review
Turn a year of scattered batch, lab, deviation, and stability records into an inspection-ready APR/PQR — in an afternoon, not a month.
Manual effort today
20–40 hours across QA
04
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
05
Data Integrity Assessment
Quality Records · Workflow
Turn system records, audit-trail configurations, access matrices and procedures into an inspection-ready data integrity assessment — mapped to ALCOA+ across the data lifecycle, drafted, independently QC'd, and ready for review in an afternoon, not weeks.
Manual effort today
Days across QA and IT
06
Standard Operating Procedure (SOP)
Quality Records · Workflow
Turn your process know-how and reference SOPs into a controlled, sign-off-ready procedure — in an afternoon, not weeks.
Manual effort today
15–30 hours drafting and cross-checking across QA and SMEs
07
Recall / Field Alert Report (FAR)
Quality Records · Workflow
Turn a distributed-product quality event into a filed-and-defensible Field Alert Report, recall strategy, or closure record — drafted, reconciled, and ready for QA sign-off in an afternoon, not a fortnight.
Manual effort today
Days of QA and regulatory time reconstructing dates from email, rebuilding distribution by hand, and re-arguing scope
08
SOP Review
Quality Records · Review
Performs a structured technical review of an authored SOP CoDraft against site standards, regulatory framework, and governing master documents.
Manual effort today
2–4 hours per SOP review
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 deviation opens
The investigation starts with the record, not a blank form
- Before
- The owner spends the first days collecting batch records, logbooks and prior events by hand, then rebuilds the timeline in a template.
- With Sofie
- Sofie drafts the investigation in your format from the workspace records, with the timeline sourced line by line and gaps marked as data requests.
Change control review
Impact assessments arrive before the meeting
- Before
- Five functions are chased for impact opinions, and the classification is argued from memory in the room.
- With Sofie
- Sofie compiles each function's impact from the affected documents and applicable guidance, so the meeting starts from a cited draft.
Annual product review
The PQR tables build themselves
- Before
- QA pulls logs from several systems, retypes tables and reconciles counts before anyone can write a conclusion.
- With Sofie
- Sofie gathers the data into a CoSheet, trends it and drafts the review, leaving reviewers to check the basis and sign off.
“Complex questions used to take hours. Sofie brings the risk-based thinking and regulatory backing together instantly. My responses are sharper, faster, and defensible from the start.”
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.
CoSheet
Spreadsheets Sofie can read, fill, chart and explain.
Workflow Library
116 prebuilt biopharma workflows, ready to configure and run.
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.