Qualification records, CAPA history, and risk decisions should already be structured, current, and complete. VendorVigilance makes that the default.
QA owns the compliance standard for vendor oversight. Qualification programmes, audit findings, CAPAs, risk assessments: all of it must be defensible under regulatory scrutiny.
But most QA teams still run it on shared drives, spreadsheets and email.
QA ends up permanently reactive, handling issues as they surface instead of seeing them coming.
Audit reports sit in a shared drive, checklists in a folder, and expiry dates in a spreadsheet someone updates when they remember. Nothing tracks them automatically, and there's no single view of where every vendor stands against its qualification obligations.
Resolution timelines slip because there's no enforced due date, no owner on record, no structured status. Evidence of closure is scattered across inboxes and file shares. When an inspector asks to see the CAPA history, it has to be reconstructed.
Quality issues raised across the organisation (by Clinical Operations, by Vendor Management, by audit teams) end up in different systems. QA is blind to the emerging picture until it surfaces as an inspection finding.
Without visibility into the contracting and study activation timeline, QA cannot schedule qualification proactively. Vendors become active before they're qualified. Studies begin before oversight is in place. The regulatory exposure is immediate.
Template-driven qualification workflows for on-site audits, remote audits, and desktop reviews. Define the sections, questions, and evidence requirements that match your SOPs. Every qualification record is associated with the vendor, the study, and the relevant contracts, providing the context a standalone document cannot.
Qualifications are flagged Expiring Soon 90 days before expiry and marked Expired the day they lapse, so none lapse unnoticed.
Audit findings are graded (Minor, Major, Critical) with serious breach flagging and structured CAPA workflows. Every open finding has a due date, an owner, and a documented status, surfaced on your dashboard so nothing stays invisible.
When a CAPA due date arrives, the system flags it. When it's resolved, the closure is recorded with evidence. The inspector sees each issue raised, assigned, resolved, and verified in one trail.
Six record types for clinical vendor oversight: four risks and two issues. Quality issues with root cause analysis. Emerging risks with three-dimensional assessment. TOROs and CTQFs associated with specific studies. Every risk item carries a computed Risk Score for prioritisation across the portfolio.
QA doesn't need to own the vendor relationship to own the quality standard. Risks & Issues gives you visibility into every risk and issue, regardless of which function raised it.
Every change to every record (qualification decisions, CAPA updates, risk assessments, status changes) is timestamped, attributed to a specific user, 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.
QA is notified when a qualification approaches expiry, when a CAPA due date arrives, when a new vendor is added to a study that requires attention. Nothing depends on someone remembering to send an email.
Qualification records, CAPA history, and risk decisions are structured and current every day, so the weeks before an inspection look like any other.
Expiry dates surface 90 days ahead, renewal workflows begin automatically, and every qualification is associated with its vendor, study, and contracts.
The hours spent chasing document status, compiling evidence, and manually tracking CAPA due dates are redirected to the oversight work that actually requires professional judgement.
Every function that depends on the oversight picture can see it. When QA completes a qualification, the study team knows. When a risk is raised, the responsible parties are notified.
A one-hour walkthrough of how your vendors, studies and qualifications would look in VendorVigilance.
No commitment required.
