VendorVigilance replaces fragmented spreadsheets with a single, current view of your entire vendor portfolio across all studies: qualifications, contracts, risks, and performance.
Vendor Alliance Management is expected to hold the full picture of outsourced clinical operations. In practice, that picture is assembled from four different places, and by the time it is assembled, something has changed.
Time goes on assembling information that should already exist, and strategic oversight gets what's left.
Qualification expiry dates slip past unnoticed until a study team discovers they cannot proceed. A contract renews automatically on unfavourable terms because the renewal window was missed. Getting the full picture on any one vendor requires pulling data from QA's spreadsheet, the contract tracker, the risk log, and an email thread from six months ago.
A quality issue raised by Clinical Operations, an audit finding from QA, an emerging risk identified during a quarterly business review: each ends up in a different system. Trends that should be visible across the portfolio stay invisible until they become inspection findings.
Without a mechanism to aggregate vendor performance data, a vendor whose quality is declining over two quarters looks the same as one performing well until a study is affected.
When the regulatory inspector arrives, the evidence of oversight has to be assembled under pressure — pulling together qualification records, CAPA histories, and risk decisions from disconnected sources. The late nights before an inspection come round every time.
Every vendor has a comprehensive record: services, subcontractors, associated studies, contacts, and the complete history of every qualification, contract, selection, and risk item. Accessible in one place, through a tabbed detail page that shows every associated record without switching tools.
Qualifications move to Expiring Soon 90 days before expiry and to Expired the day they lapse, automatically. The structured workflow means every qualification follows a consistent process, and the record is always audit-ready.
Renewal windows are flagged at 90 days without relying on someone remembering to check a spreadsheet. MSA, SOW, and CDA/NDA contracts are associated with vendors, studies, and services so the governance picture is always complete.
A structured framework for every category of risk: baseline risks auto-generated from vendor type templates, emerging risks, quality issues with CAPA tracking, and audit findings. All in one place, all associated with vendors and studies, all with documented decisions and resolution tracking.
Qualifications pending or expiring, contracts approaching renewal, risk items requiring attention, overdue deliverables: all surfaced on your dashboard without having to hunt for them. It's the portfolio-level view the role needs.
Everyone responsible for a record is notified when it changes. Every change to every record is timestamped, attributed, and tamper-proof. The audit trail meets 21 CFR Part 11 and EudraLex Annex 11 requirements. Inspection evidence is maintained continuously as a by-product of how the platform works.
The time spent pulling information from fragmented sources is recovered and redirected to the oversight and strategic work the function exists to do.
Trends that were previously invisible become visible in time to act. A vendor with three quality issues in two quarters is flagged before it becomes an inspection finding.
The evidence of oversight builds up as a continuous record of how the organisation manages its vendors, so there's nothing to produce under pressure when the inspector arrives.
Vendor Alliance Management becomes the function that provides the organisation's complete and reliable view of its vendor portfolio.
A one-hour walkthrough of how your vendors, studies and qualifications would look in VendorVigilance.
No commitment required.
