Solutions · Supply Chain
Supply work thatkeeps the risks in view.
Sofie qualifies suppliers, builds batch records and supply plans, and keeps track of the regulatory record of the companies you depend on.
Your sequences
Supplier 483 watch
Regulatory change published
Weekday quality brief
Every weekday 7:00
Meeting follow-ups
Transcript ready
USP revision watch
Regulatory change published
When
FDA posts a Form 483 for a approved supplier
40 suppliers · 57 sites
Only if
Observations mention sterility or aseptic processing
Checked on each posting
Then
Run Supplier Risk orchestration
Updates the Supplier risk Surface
Then
Draft notice to Quality
Needs approval before sending
Run log · today
Checked every 6 hSequences: scheduled and event-triggered work that runs while you are away, with approvals where it matters.
Asupplier'sinspectionhistory,alane'sexcursionrules,amaterial'sexpiry:thefactsthatmatterarescattered.Sofiegathersthemandtellsyouwhentheychange.
Work Sofie takes on
Supply chain work Sofie takes on
18 supply chain workflows covering suppliers, batch records, planning and logistics.
01
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
02
Master Batch Record (MBR)
Supply Chain · Workflow
Turn your process, formula, and equipment train into a complete, execution-ready Master Batch Record — every step, parameter, and check in place — in an afternoon, not weeks.
Manual effort today
30–60 hours across MSAT and production
03
Clinical / IMP Supply Plan
Supply Chain · Workflow
Turn your protocol, demand assumptions, and packaging data into a complete clinical / IMP supply plan — demand forecast, supply strategy, coverage and expiry, distribution and cold-chain, and risk/contingency — in an afternoon, not weeks.
Manual effort today
30–60 hours across clinical supply and QA building demand models, coverage tables, and distribution plans by hand
04
Production Scheduling / Campaign Plan
Supply Chain · Workflow
Turn demand, capacity, material, changeover, and calendar constraints into a sequenced, capacity-leveled production schedule — drafted, independently QC-checked, and ready for S&OP review, with a live dashboard alongside the document.
Manual effort today
Days across planning and MSAT
05
Logistics / Cold-Chain Lane Qualification
Supply Chain · Workflow
Turn a route map, a shipper spec and a pile of logger files into a defensible lane qualification — protocol before you ship, report after — drafted, challenged and gap-checked in an afternoon.
Manual effort today
Weeks of back-and-forth across logistics, QA and the 3PL
06
Serialization & DSCSA/FMD Compliance Plan
Supply Chain · Workflow
Turn a supply chain map and a set of market obligations into an executable serialization and traceability compliance plan — obligation by obligation, node by node, partner by partner — in an afternoon, not a quarter.
Manual effort today
Weeks of workshops across quality, IT, packaging and supply chain
07
Drug Accountability & Reconciliation
Supply Chain · Workflow
Turn shipment, dispensing, return and destruction records into a reconciliation that shows its working, classifies every discrepancy, and names what blocks closeout.
Manual effort today
Days per site rebuilding counts by hand in a spreadsheet, then arguing over which number is right at the closeout visit
08
Purchase Requisition / Sourcing Package
Supply Chain · Workflow
Drop in your requirement spec, supplier quotes, cost data, and predefined award criteria.
Manual effort today
Hours spreadsheeting apples-to-oranges quotes by hand
09
Supply Chain Risk & Continuity Plan
Supply Chain · Workflow
Authors or independently reviews a single-asset Supply Chain Risk Assessment & Business Continuity Plan for a regulated drug product or material.
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.
New supplier
Qualification evidence, mapped to criteria
- Before
- Supplier quality gathers questionnaires, certificates and audit reports, then maps them to criteria by hand.
- With Sofie
- Sofie reads the package, checks it against your criteria and the supplier's FDA record, and drafts the assessment with sources.
Overnight
A supplier's inspection outcome reaches you first
- Before
- A Form 483 at a key supplier is noticed weeks later, in the news or at the next audit.
- With Sofie
- A Sequence checks the regulatory record for your approved suppliers and notifies you with the evidence when something is posted.
Quotes come in
Like-for-like comparison
- Before
- Quotes in different formats are reconciled into a spreadsheet one line at a time.
- With Sofie
- Sofie normalizes the quotes into a CoSheet and drafts the sourcing package with the differences called out.
“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
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.