Solutions · Analytical Development
Method work,written up as you go.
Sofie drafts development plans, validation protocols and stability reports from your data, applies the relevant ICH guidance, and keeps every value tied to its source.
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
Templates: your formats, filled by Sofie with the source for each field.
Theanalysisisthescience.Theprotocol,thetablesandthereportarethepaperworkaroundit.Sofietakesthepaperworksoyouranalystscanstayatthebenchandinthedata.
Work Sofie takes on
Analytical development work Sofie takes on
15 analytical development workflows, from method plans to specification justification.
01
Analytical Development Plan Author
Analytical Development · Author
Authors a cGMP-compliant Analytical Development Plan through a single-agent, two-task workflow.
Estimated time saved
~20–35 hrs per ADP document
02
Analytical Validation Plan Author
Analytical Development · Author
Authors a GMP-compliant Analytical Validation Plan (AVP) — the governing document defining scope, objectives, roles, ICH Q2(R2) validation characteristics, and evidentiary basis for analytical procedure validation activities.
Estimated time saved
~25–40 hrs per AVP document
03
Analytical Validation Protocol Author
Analytical Development · Author
Authors a GMP-compliant Analytical Validation Protocol (AVPr) — the execution-level document defining test conditions, sampling, execution procedures, and acceptance criteria for validating analytical method(s), executed under the governing Analytical Validation Plan.
Estimated time saved
~20–30 hrs per AVPr document
04
Analytical Development Report Author
Analytical Development · Author
Authors a cGMP-compliant Analytical Development Report.
Estimated time saved
~25–45 hrs per ADR document
05
Stability Study
Analytical Development · Workflow
Turn your stability data, specification, and analytical methods into a complete ICH Q1A(R2) / Q1E deliverable — drafted or independently reviewed — in an afternoon, not weeks.
Manual effort today
Days of manual table-building, trend analysis, and formatting per report
06
Specification & Justification
Analytical Development · Workflow
Turn your batch data, stability results and method validation into a specification where every acceptance criterion carries its data basis, its method feasibility and its clinical relevance — drafted, monograph-checked and gap-registered in a day.
Manual effort today
Weeks of spreadsheet archaeology and committee argument
07
Impurity Risk Assessment
Analytical Development · Workflow
Turn your route chemistry, batch data and stability results into a threshold-tested impurity assessment — covering what the chemistry predicts, not just what the chromatogram showed.
Manual effort today
Weeks of cross-referencing four guidelines by hand, thresholds recalculated in a spreadsheet nobody trusts, and the uncomfortable discovery during a deficiency response that an impurity was never qualified at all
08
Comparability Study (ICH Q5E)
Analytical Development · Workflow
A manufacturing change is only as defensible as the comparability exercise behind it.
Manual effort today
Weeks of drafting, then weeks of review cycles
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.
New method
The validation protocol starts from the method
- Before
- Parameters, acceptance criteria and test specifications are drafted by hand from the method document.
- With Sofie
- Upload the method and Sofie drafts a complete protocol, with each section traced back to the source.
Stability pull
Tables and trends without the formatting days
- Before
- Results are copied into report tables, trended in a separate spreadsheet and formatted by hand.
- With Sofie
- Sofie builds the tables and trends in a CoSheet and drafts the report around them for review.
Specification setting
Limits justified from the data, not after it
- Before
- The justification narrative is written to fit numbers that were already chosen.
- With Sofie
- Sofie assembles batch history, guidance and compendial context first, then drafts a justification your team can challenge.
The platform behind it
Part of one connected platform
Templates
139 prebuilt templates, and your own formats, filled with sources attached.
CoSheet
Spreadsheets Sofie can read, fill, chart and explain.
CoDraft
Word-faithful documents Sofie drafts, redlines and cites with your team.
Research & Chat
Deep research across your files and the web, every claim cited.
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.