Introducing AI Compliance Intelligence: scan your QMS like CVE scanners scan code
Today we’re launching AI Compliance Intelligence — continuous AI-powered analysis that flags missing controls, overdue reviews, and risk drift across 30+ standards in real time.
A practical guide to 21 CFR Part 11 e-signatures in 2026
What changed in the FDA’s 2025 guidance update, what auditors actually look for, and how to implement compliant e-signatures without slowing your team down.
Quays vs Qualio vs MasterControl: an honest comparison
A deep look at strengths, gaps, and total cost of ownership across three popular QMS platforms — written by someone who has implemented all three.
Setting up SAML SSO with Okta in 10 minutes
Step-by-step walkthrough with screenshots, including SCIM 2.0 provisioning and group-based role mapping.
Surviving an unannounced FDA inspection: 7 lessons learned
Real war stories from QA leaders who passed (and failed) surprise inspections — plus a checklist you can hand your team today.
How Acme Pharma cut audit prep time by 78%
From 12 weeks of binders to 3 days of dashboards — the playbook one mid-size pharmaceutical company used to transform their audit posture.
Designing CAPA workflows that people actually follow
The 5-step CAPA workflow our most successful customers use, with templates you can copy directly into your own QMS.
ISO 13485 for medical device startups: when to start, what to skip
Most medical device startups either start their QMS too late (and pay for it during 510(k)) or build a 200-SOP monster too early. There’s a middle path.
SOC 2 + ISO 27001: how we got both certifications without doubling the work
Our CISO breaks down the unified control framework that let us achieve SOC 2 Type II and ISO 27001 in the same audit cycle, with one set of evidence.
How we deploy zero-downtime database migrations to a Part 11 validated environment
Validated environments and continuous deployment have a famously tense relationship. Here’s the engineering pattern we use to ship 4x per day without ever taking the platform offline.