Pharmacovigilance 4.0 · Digital Monitoring

AI Supported – Daily monitoring of websites

Operational service supporting Drug Safety departments: AI executes the repetitive part — scheduled navigation, dated screenshots, safety pre-filtering — while the PV officer keeps the safety-relevance judgment and final validation.

Book a 60-minute session

Why manual monitoring is no longer enough

Increasing volume of digital channels to monitor (sponsored sites, social, AIFA Facebook keywords)
GVP Module VI requires complete, traceable and reproducible audit trail
Manual collection is slow, error-prone and not always reproducible
The PV officer's time is qualified — it must be spent on judgment, not on repetitive navigation
Missing evidence on safety signals exposes the company to regulatory risk

Workflow AI-supported monitoraggio Farmacovigilanza

~ 130 h/year

Operator time freed up

Average DSU scope; recalibrated on customer

3 channels

Daily monitored channel types

Websites · social · AIFA keywords

100%

Complete audit trail

Dates, URL, screenshot, reproducible hash

GVP-ready

GVP perimeter coverage

Module VI · Annex 11 · 21 CFR Part 11

Scenario 1 · AI-assisted

Generic social networks

Weekly · automatic execution

Automatic extraction of last-30-day posts
Full comments collection
Highlight only hits
Posts table + comments table
Officer reads only what's relevant

Operator time: ~45 min / week

Scenario 3 · AI-assisted

Facebook AIFA — keyword search

Weekly · 45 keywords in batch

Massive parallelized search
SERP screenshot for each keyword
Automatic audit trail log
Evidence organized by keyword
Officer validates in bulk

Operator time: ~25 min / week

Indicative total: ~130 hours/year of qualified operator time concentrated only on evidence requiring judgment (average DSU scope; values to be recalibrated on the customer's actual scope).

// Deliverable

Outputs and evidence produced

Daily dated screenshots, indexed and archived
Structured CSV/Excel reports with safety pre-filter
Reproducible audit trail (date, time, URL, hash)
Monthly retention dossier ready for inspection
GVP-compliant documentation, EudraLex Annex 11 & 21 CFR Part 11

Parametro	Processo manuale	Processo AI-assisted	Impatto annuo
Sponsored websites	~1 hour/day of manual navigation	~20 min/day of AI-assisted review	~ 195 h/year operator saving
Generic social networks	~3 hours/week full reading of posts + comments	~45 min/week only pre-filtered hits	~ 117 h/year operator saving
Facebook AIFA · keywords	~2 hours/week keyword-by-keyword search	~25 min/week parallelized batch	~ 78 h/year operator saving
Audit trail	Manual post-hoc compilation	Reproducible automatic audit trail	Compliance with Annex 11 / 21 CFR Part 11
Reproducibility	Operator-dependent	Identical, replicable execution	Inspection robustness
Safety decision	PV officer	PV officer (human-in-the-loop)	Unchanged: judgment remains human
Evidence traceability	Manual screenshots, mixed archiving	Dated screenshots, ordered archive	Inspectability-ready
Approximate annual saving: ~130 hours of qualified operator time, reinvested in safety-relevance judgment.

Who it is designed for

QPPV — Qualified Person for Pharmacovigilance
Drug Safety Managers and PV officers
QA / CSV process owners in regulated pharma
MA Holders with EU/AIFA monitoring obligations
CROs providing PV services to MAHs

Operational benefits

Time reclaimed

The qualified officer time is concentrated only on evidence that actually requires safety judgment.

Reproducible audit trail

Each execution leaves a dated, reproducible and inspectable trace, aligned with GVP and Annex 11.

Configurable on scope

Sites, social and keywords are configured on the customer's real perimeter, not on a standard template.

Human-in-the-loop

AI never decides alone: the PV officer keeps validation, signature and final safety responsibility.

Good Pharmacovigilance Practices

EMA GVP Module VI

Management and reporting of adverse reactions, including from digital sources.

EU GMP

EudraLex Annex 11

Computerised systems in GxP environments: audit trail, data integrity, electronic signatures.

US FDA

21 CFR Part 11

Electronic records and electronic signatures: integrity, traceability, reproducibility.

Framework

GAMP 5 Second Edition

Risk-based approach to computerized system validation in regulated environments.

Human-in-the-loop. AI executes the repetitive part (navigation, screenshots, pre-filter). The judgment on safety-relevance and the final validation always remain with the responsible Pharmacovigilance officer. This service does not replace the human decision-maker — it frees up qualified time, concentrating it on truly relevant evidence.

AI Supported – Monitoraggio giornaliero dei siti web

Servizio operativo di supporto ai reparti di Farmacovigilanza dell’industria farmaceutica per la sorveglianza schedulata e tracciabile dei siti web e dei canali digitali rilevanti, in coerenza con le Good Pharmacovigilance Practices (GVP), l’EudraLex Annex 11, il 21 CFR Part 11 e il framework GAMP 5 per i sistemi computerizzati in ambienti regolati.

L’approccio è AI-assisted: la componente AI esegue la parte ripetitiva (navigazione, screenshot, pre-filtro, raccolta strutturata), mentre il giudizio sulla rilevanza ai fini di safety resta in capo al responsabile di Farmacovigilanza. Il servizio non sostituisce il decisore umano: ne libera il tempo qualificato concentrandolo sulle sole evidenze rilevanti.