Solutions · Commercial Biopharma
Consistency acrosssites, markets and functions.
Sofie applies the same standards, templates and review points at every site, so product reviews, change strategies and lifecycle work read as one organization.
LB-204
Compound
Fed-batch upstream
Process
Protein A capture
Process
IL-23p19
Gene/Protein
Plaque psoriasis
Disease
FDA
Regulatory Body
Northwind · Alameda
Site
Northwind · Durham
Site
Observations
LB-204 hold limits
94%Clarified harvest validated to 72 h at 2–8 °C; HT-7 has no supporting study yet.
3 sources
Northwind engineering run
88%SUB-2000 qualified; engineering run held for the week of Nov 10.
2 sources
Rules
Format outputs for GMP documentation
Cite page numbers for every workspace claim
Use ICH Q5E terminology for comparability
Memory: institutional context that carries forward, under the governance your administrators set.
Atscale,theproblemisrarelycapability.Itisconsistency:thesamequestionanswereddifferentlyattwosites.Sofieworksfromonesetofstandardseverywhere.
Work Sofie takes on
Work Sofie takes on across a commercial organization
Lifecycle, quality and supply workflows that run the same way at every site.
01
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
02
Annual / Periodic Report
Regulatory & CMC · Workflow
Turn twelve months of change controls, stability data, labeling revisions and commitments into the periodic report your authority expects — with the period boundary held and nothing quietly absorbed that should have been filed on its own.
Manual effort today
Four to six weeks of chasing owners for what changed, rebuilding the change list from memory, and discovering during review that something in the annual report should have been a supplement filed nine months ago
03
Change Strategy
Quality Records · Workflow
Turn a proposed change into a strategy you can defend: the reporting category in every market against its own cited provision, the data package each path really demands, and a recommendation that shows its own reasoning.
Manual effort today
A month of opinions
04
Process Monitoring & Trending (Continued Process Verification)
Supply Chain · Workflow
Turn a period of batch data into a continued process verification record: your rules applied to the right limits, capability only where it is valid, and every signal followed to an action.
Manual effort today
Weeks of chart-building, then an argument at the review about which limit applied and whether the capability number means anything
05
Continued Process Verification Summary Author
CQV · Author
Authors a GMP-compliant Continued Process Verification (CPV) Summary — the periodic execution-results report documenting monitoring data, statistical trending, process capability results, and risk/signal outcomes generated during routine commercial manufacturing against the approved CPV Plan.
Estimated time saved
~20–35 hrs per CPVS document
06
Lifecycle Management Plan Author
Tech Transfer · Author
Authors a GMP-compliant Lifecycle Management Plan — the governing document for post-approval lifecycle management, bridging Continued Process Verification and Annual Review outcomes into forward-looking Established Conditions definition, Post-Approval Change Management Protocol (PACMP) strategy, and change category risk classification.
Estimated time saved
~25–40 hrs per LMP document
07
Supplier Qualification
Supply Chain · Workflow
Turn supplier questionnaires, audit reports, certificates, and quality history into a complete qualification plan or assessment — risk-categorized, evaluated against your predefined criteria, with a clear recommendation — in an afternoon, not weeks.
Manual effort today
20–40 hours of supplier-quality time gathering evidence, mapping it to criteria, and formatting the assessment by hand
08
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
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 post-approval change
One market's answer is not assumed for the rest
- Before
- Reporting categories are argued from memory, and the data package grows once the team is committed.
- With Sofie
- Sofie compares requirements across the authorities you file with and drafts a change strategy with the evidence for each market.
Product reviews at three sites
The same review, done the same way
- Before
- Each site builds its PQR in its own format with its own interpretation.
- With Sofie
- A shared template and workflow produce the review the same way at each site, with site data and sources attached.
Governance
Standards that stay in force
- Before
- Guidance on how the organization works lives in slide decks and individual habits.
- With Sofie
- Directives, shared prompts and skills apply your standards every time Sofie works, and administrators govern what it retains.
“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
Memory
Institutional context that carries forward, under your governance.
Templates
139 prebuilt templates, and your own formats, filled with sources attached.
Sequences
Scheduled and event-triggered work that runs while you are away.
Regulatory Intelligence
Nine authorities, cited and monitored every day.
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.