EudraVigilance Metrics and KPIs for QPPVs

Dormant accounts — delayed literature searches Unresolved rejections — continuing exposure from reports not successfully accepted or corrected Open signal inventory — completeness of EV acknowledgements Management review completion — coding validation accuracy

Use only the vendor’s own summary reports without checking definitions or evidence Define measurement methods and targets contractually, trend performance and require investigation of material deviations Monitor vendor volume only because quality remains the vendor’s responsibility Apply different undocumented calculations to each vendor

It is displayed using a graphical format It is calculated at least annually It can support a defined management decision or intervention It includes the largest possible number of data points

Removing case identifiers from the underlying data Drill-down from the aggregate KPI to individual cases and linked supporting artefacts Displaying only the current month without historical trends Using a single overall metric for all products and vendors

Retain only the final cases entered into the safety database Retain the validated search strategy, search results, screening logs and processing timestamps Measure only the number of articles reviewed by the literature team Use an unvalidated search strategy if the review is performed frequently

A list of all users with access to EVDAS Completed review outputs, documented conclusions, signal decisions and escalation evidence where applicable The total number of searches performed without review conclusions A quarterly count of all cases submitted to EudraVigilance

The exclusions should remain undocumented to preserve flexibility The exclusions and their rationale should be predefined, consistently applied and retained for inspection Only the QPPV should know which cases were excluded Excluded cases should be counted as on-time submissions

A dashboard screenshot and an annual workload total A defined numerator and denominator, named owner, controlled data source, review cadence, escalation pathway and documented management action A target copied from another company without risk assessment A list of metrics with no record of review or follow-up

Allow each team to define the due date according to local practice Use a documented and consistently applied due-date definition aligned with applicable regulatory requirements Calculate timeliness only from the date the case was entered into the safety database Exclude late cases whenever the operational team considers the delay understandable

To demonstrate the total volume of work completed by each operational team To provide rapid visibility of compliance and patient-safety risks requiring oversight or intervention To rank individual case processors according to productivity To replace the organisation’s quality management system