Solutions · Manufacturing & CQV
Qualification and validation,traced end to end.
From URS to PQ and continued process verification, Sofie builds the traceability, drafts the protocols and reports, and checks that every requirement has evidence behind it.
Titer by lot
g/L · spec ≥ 3.0
Mean titer
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Mean purity
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Pass
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Review
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CoSheet: a real spreadsheet Sofie can fill, check, chart and explain.
Validationfailsontherequirementnobodycarriedacross.Sofiekeepsthethreadfromuserrequirementtotestresult,andshowsyouwhereitbreaks.
Work Sofie takes on
Manufacturing and CQV work Sofie takes on
CQV and process development workflows, each producing the document your quality system expects.
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
Design Qualification (DQ)
CQV · Workflow
Turn your user requirements and design package into a design qualification that traces every requirement to the drawing that satisfies it — in an afternoon, not three weeks of spreadsheet wrangling.
Manual effort today
Two to three weeks building a traceability spreadsheet by hand, with verdicts entered from memory of a design review meeting
03
Equipment & Utility Qualification
CQV · Workflow
Turn your protocols, execution records and calibration certificates into qualification documents where every result traces to a record — in an afternoon, not a fortnight of transcription.
Manual effort today
Ten to fifteen days per stage transcribing results into a report, chasing which calibration certificate covered which instrument, and discovering at QA review that three tests have no attached data
04
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
05
Process Validation Protocol Author
CQV · Author
Authors a GMP-compliant Process Validation Protocol — the execution-level document detailing scope, sampling plans, acceptance criteria, and test methods for process validation activities spanning engineering runs through PPQ.
Estimated time saved
~20–35 hrs per PVP document
06
Continued Process Verification Plan Author
CQV · Author
Authors a GMP-compliant Continued Process Verification (CPV) Plan — the governing document that establishes the ongoing monitoring program verifying the commercial manufacturing process remains in a validated state of control following Process Performance Qualification (PPQ) disposition.
Estimated time saved
~20–35 hrs per CPVP document
07
IQ/OQ/PQ Review
CQV · Review
Performs a structured technical review of a complete three-protocol qualification package (IQ + OQ + PQ) against the upstream URS, DQ, and site engineering standards.
Manual effort today
8–16 hours per package review
08
Process Development Report Author
Process Development · Author
Authors a GMP-compliant Process Development Report (PDR).
Estimated time saved
~25–45 hrs per PDR document
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.
Design review
Traceability without the spreadsheet archaeology
- Before
- Requirements are retyped into a matrix and verdicts entered from memory of the design review meeting.
- With Sofie
- Sofie maps each requirement to the design documents in a CoSheet, marks the verdict with its source, and lists the ones with no evidence.
Qualification report
Results transcribed, calibrations matched
- Before
- Engineers transcribe test results and chase which calibration certificate covered which instrument.
- With Sofie
- Sofie drafts the report from the executed protocol and attached data, and flags tests without results before QA sees them.
Quarterly CPV
Trending you can explain
- Before
- Charts are rebuilt each quarter, and the review debates which limit applied.
- With Sofie
- Sofie trends the parameters in a CoSheet against the limits in your plan and drafts the summary with the basis for each call.
“Sofie changes everything, except the way you work. It just makes it a whole lot easier and faster.”
The platform behind it
Part of one connected platform
CoSheet
Spreadsheets Sofie can read, fill, chart and explain.
Templates
139 prebuilt templates, and your own formats, filled with sources attached.
Orchestrations
Specialized agents coordinated across multi-step work, with human review points.
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.