AI regulatory surveillance — targeted to your products, not a firehose.
V5 scans regulator sites, standards bodies and industry sources continuously, filters against your product portfolio, sites and processes, and delivers a short daily digest of what actually matters — with the underlying document and a proposed impact-assessment stub.
What breaks without this.
Nobody has time to read every guidance
40+ regulators publish weekly; your RA team samples what they can and misses the rest.
Impact assessment is entirely manual
A published guidance sits in a folder for weeks before someone maps it to your products.
Warning letters teach the industry, one at a time
The 483s issued to peers are the best syllabus you'll ever get — if you read them.
Records-by-execution. Compliance, by design.
Continuous multi-source ingest
FDA guidances, warning letters, recalls, 483s; EMA guidelines and referrals; MHRA safety notices; PMDA bulletins; TGA safety updates; ISO / ICH / USP updates.
Targeted to your portfolio
Product classes, dosage forms, sites, processes — the filter is your V5 master data, not a keyword list.
Daily short-form digest
A 5-minute read that surfaces only what matters, with the source link and a plain-English summary.
Impact-assessment stub drafted
For each hit, V5 drafts an impact assessment linking the guidance passage to your affected SOPs, products or processes.
Traceable to closure
Each hit becomes a regulatory-change record with owner, SLA, impact and closure evidence.
What to look for when you're buying.
Regulatory surveillance is only useful when it's filtered. Criteria that separate a firehose from a decision-support tool.
Source breadth
What it tests: How many regulators and standards bodies are covered?
Why it matters: Portfolio coverage matters.
V5: 40+ regulators and standards bodies.
Portfolio-driven filter
What it tests: Does the filter run against your V5 master data or a keyword list?
Why it matters: Keyword lists miss and over-fire.
V5: Master-data driven.
Impact assessment stub
What it tests: Does each hit come with a drafted impact assessment?
Why it matters: Hits without impact assessments become inbox items.
V5: Drafted per hit.
Ownership and SLA
What it tests: Is each hit an owned record with SLA?
Why it matters: Unowned reg-changes miss.
V5: Owned with SLA.
Traceable to closure
What it tests: Is closure evidenced?
Why it matters: Auditor question.
V5: Closure evidenced with links to actions taken.
Digest cadence
What it tests: Is the digest short-form daily, or long-form weekly?
Why it matters: Long weeklies get skipped.
V5: Short daily plus themed weeklies.
Spreadsheet vs legacy QMS vs V5.
AI regulatory surveillance vs a subscription newsletter and vs a legacy RIM tool.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Source breadth | Limited | Broad | 40+ sources |
| Portfolio filter | Manual read | Keyword | Master-data |
| Impact stub | None | None | Drafted |
| Owned records | Ad-hoc | Sometimes | Native |
| Digest cadence | Weekly | Monthly | Daily + themed |
The clauses, verbatim — and how V5 answers each.
Where regulatory-change management is required.
Management of change should be applied to changes to products, processes, methods, equipment, utilities, systems, and specifications.
V5: Reg changes flow into V5 change control with impact assessment stub pre-drafted.
Design input requirements shall be documented, and shall be reviewed and approved.
V5: Standards updates flag design-input impact on affected products.
State of the art.
V5: State-of-the-art monitoring is continuous, not episodic.
Risk analysis.
V5: Reg changes flow into risk-file review with impact stub.
Step by step on the floor.
Surveillance lights up in days, not months.
- 1Day 1
Portfolio loaded
Products, sites, processes and standards subscriptions loaded from V5 master data.
- 2Day 2
Sources subscribed
Regulator and standards-body sources subscribed and filtered.
- 3Day 3
First digest
First daily digest delivered.
- 4Week 1
Impact stubs live
Impact assessment stubs drafted per hit; RA owns each.
- 5Ongoing
Closure evidenced
Each hit closes with action linked and audited.
The math, with the assumptions visible.
ROI is measured in missed-guidance risk and RA-team throughput.
Missed relevant guidance
Coverage is portfolio-driven, not sampling-based.
RA time per hit
Stub eliminates the assessment draft.
Owned closure rate
Every hit is an owned record.
One prevented late-adoption of a guidance typically pays the module for years.
What changed on the floor.
Setting
A device manufacturer with US, EU, UK, JP and CA markets and a 3-person RA team.
Before
Coverage was newsletter-based; a Notified Body finding cited late adoption of a standards revision.
After
Twelve months post-cutover, next Notified Body audit closed with no state-of-the-art findings; RA team reallocated a headcount to submission work.
Proof points
- One digest per day covering 40+ regulators
- Filter runs against your V5 master data
- Impact-assessment stub drafted per hit
- Every hit is auditable to the source document
Built to satisfy
- ICH Q10 §3.2.4 (management of change)
- 21 CFR 820.30 (design controls — regulatory input)
- EU MDR 2017/745 Annex I (state of the art)
- ISO 14971 §5 (risk management — regulatory changes)
- ICH Q9(R1) (quality risk management)
Related on V5
Frequently asked questions
Which regulators are covered?+
FDA, EMA, MHRA, Health Canada, TGA, PMDA, Swissmedic, ANVISA, CDSCO and 30+ others. Standards bodies covered include ISO, IEC, ICH, USP, PIC/S.
Can it monitor a specific device standard?+
Yes — pin any standard (e.g. IEC 60601-1-2) and get notified on version and amendment activity.
Does the impact assessment auto-close?+
No — the stub is drafted; a named RA owner reviews, decides scope and signs closure.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.