The Lab

Concepts you can poke. Every interactive here also embeds inside the briefings, so theory and practice stay on the same page.

Tool2 min

GAMP Category Finder

Answer three questions about a system and get its GAMP 5 software category, with the validation approach that follows from it.

Launch

Quiz4 min

Part 11 Myth-Buster

Eight claims about 21 CFR Part 11, all heard in real meetings. Call myth or fact and find out how deep the folklore runs.

Launch

Tool2 min

Validation Effort Estimator

Four honest questions about your system, one risk-based effort profile: the deliverable set that fits, and where teams overspend.

Launch

Game4 min

Spot the ALCOA+ Violation

Eight records from the field, each hiding a data integrity problem. Name the principle that takes the hit — if there is one.

Launch

Game5 min

Audit Trail Anomaly Hunt

Eleven rows from a LIMS audit trail, four of them wrong. Flag what an auditor would circle, then compare findings.

Launch

On the bench next

An ALCOA+ record-review game, a risk-based testing effort estimator, and an audit-trail anomaly hunt. If one of those should jump the queue, the about page tells you where to say so.