Use cases
See how we use it.
Real workflows, real facilities, real inspections. Browse our media library to see KeyPedia in the field.
01
Inspection Preparation
Know the investigator before they walk in. KeyPedia surfaces inspection histories, investigator profiles, and citation patterns across 80+ global health authorities — so your team has answers before the questions are asked.
02
Audit Readiness & Conduct
Whether you’re preparing to be audited or conducting a supplier audit, KeyPedia puts the regulatory evidence in your hands. Internal audit teams use it to close gaps before inspectors arrive. Auditors use it to build findings that hold up.
03
Observation & Report Writing
Writing a 483 response or drafting post-inspection observations requires more than good prose — it requires regulatory evidence. KeyPedia gives you the citation data to make your claims defensible and your documents inspection-grade.
04
Regulatory Monitoring & Intelligence
Don’t react to the inspection. See it coming. KeyPedia’s predictive analytics track warning letter trends, investigator activity, facility risk signals, and global guidance changes — so your team stays ahead of the regulatory curve, not behind it.
05
Supplier & Third-Party Risk
Before you sign a contract with a CMO or CDMO, pull their regulatory history. Warning letters, 483s, inspection outcomes, enforcement actions — KeyPedia surfaces everything a supplier would rather you didn’t find before the first call.
Content coming soon — browse related media →
06
Global Market Intelligence
Regulatory intelligence doesn’t stop at the US border. KeyPedia aggregates enforcement data from 80+ health authorities — FDA, EMA, NMPA, ANVISA, Health Canada, PMDA — so your team understands the global risk picture, not just the domestic one.
07
FOIA & Records Access
FDA has records on every facility it has ever inspected. Most companies don’t know how to get them. KeyPedia automates anonymous FOIA requests, verifies existing records, and retrieves hard-to-find compliance documents — in three steps.
08
Drug Quality & Testing Intelligence
Regulatory filings don’t tell the whole story. KeyPedia integrates Valisure drug quality testing data — failed tests, contamination findings, market withdrawal signals — layered on top of enforcement history for the most complete picture of product risk available.
09
Device Postmarket Surveillance
MAUDE signals, device recalls, and competitor postmarket behaviour, read the way a device quality team needs it. Devices & MAUDE by Riskbased.ai watches adverse events and recalls continuously, with control charts and benchmarks on FDA device data.
10
Drug Quality & Procurement
Directors of pharmacy and sourcing teams use the record to buy on quality, not price alone. KRA risk scores, supplier history, and independent drug quality data sit behind every purchasing decision, so green is bought and red is avoided.
11
Physical Audit & Inspection
Machines, sensors and records report constantly, but someone still has to confirm what is physically on the floor. The AR Auditor and the autonomous audit robot check every asset, every shift, against what the systems claim.
Content coming soon — browse related media →
Most software companies define a handful of use cases and check the boxes that they do them. That’s not what we do. We take our software with us to conferences, events, into inspections and facilities. We produce media and we show how we’re using it in those places and use cases. That’s what you can find in our media library. That is our use case.
KeyPedia is built for the real world.