EU GMP Annex 11 · 21 CFR Part 11 · ALCOA+
AI classifies documents, detects compliance gaps and scores supplier risk, all on your internal server.
The status quo
Supplier files today sit in shared folders with dozens of versions and no clear owner. Certificate expiries are tracked in a forgotten calendar reminder, gap analysis of Quality Agreements takes a QA specialist a full day per supplier with PDF and highlighter, and FDA Warning Letters or EudraGMDP non-compliance statements are never systematically matched against the roster. When an inspector arrives, QA spends a week assembling dossiers from email threads.
What VendorCore does
Reads every upload, identifies GMP cert, ISO cert, QA or SMF, pulls issuer, certificate number and expiry, alerts 60 days before.
Checks each Quality Agreement and Site Master File against 12 mandatory clauses, flags present, partial or missing with the page reference.
ZIP with PDF report, all documents, findings, KPIs and the full audit trail, ready before the inspector finishes coffee.
FDA Warning Letters and EudraGMDP non-compliance statements polled every 12 hours and matched automatically against your supplier roster.
SQL or Excel sync that upserts by external_ref, keeping the quality file and the ERP perpetually aligned without copy-paste.
Why this is not another SaaS
VendorCore is not a vendor management SaaS that locks your supplier records into a multi-tenant cloud. It runs on your internal server, supplier certificates and ERP data never leave the network, and the AI for classification, gap analysis and risk scoring uses your local Ollama or LM Studio models with zero per-query cost. The GAMP 5 Category 4 validation package (URS, FS, FMEA, IQ, OQ, PQ) ships with the installation, ready for QA sign-off.
No cloud, no telemetry. Certificates and ERP data never leave the network.
URS, FS, FMEA, IQ, OQ and PQ delivered with the installation.
Shares authentication, RAG and 40+ tools with the rest of your platform.
For whom
Pharma, biotech and medical device manufacturers, and the quality consultants serving them. For companies with ten or more active suppliers needing auditable traceability under EU GMP and 21 CFR Part 11.
Pilot in two weeks, no cloud setup or subscription required to evaluate.