Solutions · Suppliers to Industry
Every customer asks.Sofie helps you answer.
For suppliers of pharmaceutical packaging, drug-delivery systems, manufacturing equipment, consumables and enabling technologies, Sofie keeps customer projects, quality requirements and change notifications moving. It finds the approved sources in your records and drafts the response; your team reviews, decides and sends.
CN-26-031 change notification
Reading your sources
Notice package · CoDraft
Draft · for reviewChange notification · Major
CN-26-031 · Second molding line
P/N 4471-10, 4471-12 · Recipients confirmed by Quality
Line 4 process validation summary 4
M. Kline · Quality
Reviewer · nothing sent until approved
Change notification: Sofie reads your change record, notification policy and quality agreements, classifies the change, assembles the notice package and routes it for approval.
Yourcustomersmakemedicines,soeveryweektheyaskyoutoshowyourwork.Theanswersalreadyliveinyourrecords.Sofiefindstheapprovedsources,matchesthemtotheaskandputsafirstdraftinfrontoftherightreviewer.Yourpeoplestayaccountableforeverydecision.
Work Sofie takes on
Work Sofie takes on for suppliers to industry
Workflows behind the customer conversations suppliers have every week, from complaint responses to audits.
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
Extractables & Leachables (E&L) Study
Analytical Development · Workflow
Turn your component list, supplier packages and study data into an extractables and leachables assessment where the inventory is complete, the thresholds have a named owner, and the correlation gaps are visible.
Manual effort today
Months of assembling vendor packages of uneven scope, an inventory built from whoever remembers what is in the fluid path, and a threshold nobody can quite trace to a toxicologist when the assessor asks
04
Drug Master File (DMF)
Regulatory & CMC · Workflow
Authors or independently reviews a US Drug Master File (DMF) — Type II (drug substance/API), Type III (packaging material), Type IV (excipient), or Type V (FDA-accepted reference information) — in CTD/ICH M4Q structure per 21 CFR 314.420.
Configured to your procedures
05
Audit & Inspection Management
Quality Records · Workflow
Drafts or independently reviews any deliverable across the full audit/inspection lifecycle — Planning, Readiness Assessment, Findings & Observations, Findings Response & CAPA, and Effectiveness & Closure — for Internal Audits, Supplier Audits, and Regulatory Inspections.
Configured to your procedures
06
Quality Agreement
Quality Records · Workflow
Drafts or independently reviews a GMP Quality Agreement between a contract giver (product owner / MAH) and a contract acceptor (CDMO / CMO / contract lab), allocating GMP responsibilities, quality-system interfaces, and regulatory commitments.
Configured to your procedures
07
Proposal / RFP Response
Business Development · Workflow
Drafts or independently reviews a written response to a client RFP, RFI, RFQ, or an unsolicited/proactive proposal — end to end — so BD can move from solicitation to a review-ready proposal in one run, grounded strictly in supplied evidence.
Configured to your procedures
08
Technical Feasibility Assessment
Business Development · Workflow
Turn an incoming enquiry and your own site evidence into a defensible technical feasibility assessment — fit, capacity, gaps, risks and conditions — in an afternoon, not three weeks of round-robin emails.
Manual effort today
Two to three weeks of chasing MSAT, QC, QA and engineering for opinions, assembled into a document that quietly asserts capability nobody evidenced
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.
Complaints and quality events
From investigation to a clear customer response
- Before
- The investigation lives in your eQMS, and turning it into a response the customer can act on means rewriting findings and timelines by hand.
- With Sofie
- Sofie drafts the investigation summary and the customer response letter from the investigation record, with a source for every statement. Intake, CAPA and closure stay in your eQMS.
Change control and change notifications
Classified first, then notified on agreed terms
- Before
- Quality classifies the change, then searches agreements one by one for the products, customers and notice commitments it touches.
- With Sofie
- Sofie classifies the change against your notification policy, assembles affected products, customers, agreement commitments and old-versus-new documents, and drafts the notice package. Your team decides who gets notice.
Customer RFIs
Evidence matched to the ask
- Before
- Extractables data, TSE/BSE statements, nitrosamine assessments and registration support letters are pulled from different systems for every request.
- With Sofie
- Sofie finds the current approved sources, compares what is asked with what you have, flags any claim your evidence does not support and drafts the response for regulatory review.
Audits
The audit room, prepared
- Before
- SOPs, certificates, agreements and earlier responses are gathered by hand the week before the auditors arrive.
- With Sofie
- Sofie assembles the evidence index with gaps flagged, and afterwards drafts responses to findings for QA review. Official observations and approved CAPAs stay in your QMS.
Sustainability
Evidence attached to every answer
- Before
- EcoVadis, PSCI and customer CSR questionnaires ask for evidence behind every answer, and each one is assembled again from scratch.
- With Sofie
- Sofie drafts each response from your records and earlier answers with the evidence attached, and flags where a new answer would differ from one already given. Your team reviews before it goes out. Scorecards and ESG reporting stay in their own systems.
The platform behind it
Part of one connected platform
Workspaces
Every program, site and client, with its files, people and history in one place.
CoDraft
Word-faithful documents Sofie drafts, redlines and cites with your team.
Templates
Prebuilt templates and your own formats, filled with sources attached.
Regulatory Intelligence
Nine authorities, cited and monitored every day.
Start with one customer request.See the evidence behind it.
In a working session we pick a live customer request, such as a complaint response, change notification, RFI or questionnaire, load the approved records it depends on, and agree who reviews Sofie's drafts. Then you decide whether to expand.