VendorVigilance
Vendor Management System for Pharma and Biotech

Pass regulatory inspections with confidence, not last-minute preparation

Qualifications, contracts, and risks for every vendor, in one audit-trailed record from selection to study close-out. The evidence builds as your team works, so there's nothing to assemble when the inspector asks.

Supports 21 CFR Part 11
ICH E6(R3) aligned
Validated every release
The problem

Vendor oversight wasn't designed for how pharma works

01

Fragmented processes

Selection criteria rebuilt for every procurement. Qualification templates that differ between studies, between team members, between quarters. Risk assessments with no common framework.

The quality of oversight depends on who is doing it, not the system they work in.

02

Invisible data

Qualification dates, contract terms, risk scores, performance observations: the information exists, but it lives in spreadsheets, shared drives, and email threads. No function has a complete, current view.

Decisions are made on partial information. Trends stay invisible until they become incidents.

03

Siloed communication

QA completes a qualification without notifying the study team. A risk is raised without reaching the team deploying that vendor. A contract renewal is processed without informing the qualification owner.

Critical information travels through informal channels that break down under pressure.

These three failures create exactly the conditions regulatory inspections are designed to find.

Modules

From selection to close-out

VendorVigilance is modular. Enable the capabilities your organisation requires today and expand as your programme matures.

Vendors

Central registry of all vendors, services, subcontractors, and studies. Every vendor in one place with an aggregate risk score.

Selections

Structured evaluation workflows from direct awards to competitive RFPs with template-driven scoring and analysis.

Qualifications

Template-based qualification processes with automatic expiry tracking. On-site, remote, or desktop configured to your standards.

Governance

Contracts, deliverables, KPIs, and meetings. Track obligations, measure performance, and flag expiries before they lapse.

Risks & Issues

Six record types built for clinical vendor oversight: four risks (emerging, baseline, TOROs, CTQFs) and two issues (quality issues, audit findings).

Requests

Structured questionnaires sent to vendors with response tracking. Draft, send, collect, and review all in one workflow.

Tasks

General-purpose work items linked to any object in the system. Track activities across your entire vendor portfolio.

Reports

Fifteen built-in reports across selections, qualifications, deliverables, KPIs, risks, and more. Bar chart visualisation, filtering, and image export.

Core platform: Dashboard, audit trail, notifications, role-based access control, and global study filter included with every deployment.

VendorVigilance Modular Architecture - Vendor Registry Central Hub
Who it's for

One record for every function that touches a vendor

01

Quality Assurance

We need to prove our oversight programme works — not reconstruct it before every inspection.

Run qualification programmes, track audit findings and CAPAs, and maintain inspection-ready documentation across your entire vendor portfolio. VendorVigilance replaces the manual assembly of evidence with a continuous, auditable record.

Quality Assurance use case→
Quality Assurance vendor oversight dashboard
02

Clinical Operations

We can't wait for QA to tell us a vendor qualification has expired. We need to see it ourselves.

Monitor vendor performance against study timelines, track deliverables, and ensure the vendor lifecycle stays synchronised with your clinical programme. The global study filter puts everything in context instantly.

Clinical Operations use case→
Clinical Operations vendor management dashboard
03

R&D Sourcing

Every selection runs differently because there's no standard process to follow.

Manage vendor evaluations from requirements through award with template-driven selection workflows and standardised scoring. Access existing qualification status, performance history, and risk context from the vendor registry so selection decisions draw on everything the organisation already knows about each vendor.

R&D Sourcing use case→
R&D Sourcing vendor selection and scoring dashboard
04

Vendor Alliance Management

The information exists — it's just in four different systems and none of them talk to each other.

See the full vendor portfolio in one place: qualification status, contract coverage, open risks, and performance data without assembling it from disconnected spreadsheets and shared drives. VendorVigilance gives Vendor Alliance Management one current view across every vendor and study.

Vendor Alliance Management use case→
Vendor Alliance Management consolidated vendor portfolio dashboard
05

Executive Leadership

I need a portfolio-level view of vendor risk without commissioning a report every time.

Real-time visibility into vendor risk scores, qualification status, contract coverage, and programme health whenever you need them. Fifteen built-in reports with one click.

Executive Leadership use case→
Executive Leadership vendor risk and portfolio dashboard
Why VendorVigilance

Built for clinical vendor oversight

Designed around how clinical QA works.

VendorVigilance was designed from day one for GxP vendor management in clinical trials. It isn't a procurement tool adapted for pharma, or a QMS with a vendor module added later.

Compliance is in the data model.

Every change lands in a 21 CFR Part 11 audit trail. Access is scoped by study, module, and object type, and risk management follows ICH E6(R3).

Your team configures it without IT.

Template libraries for qualifications, selections, KPIs, meetings, and vendor types, all edited in the app's form builder. No scripting and no development work.

Every record belongs to a study.

The global study filter ties each qualification, contract, risk, and deliverable to the clinical programme it serves, so the vendor lifecycle and the study lifecycle stay in step.

Before and After - Unified Vendor Management Platform

See VendorVigilance in action

One hour, your vendor portfolio, and a clear view of what inspection-ready actually looks like.

No commitment required.