Insights
Expert perspectives on quality management, regulatory compliance, audits, and risk-based systems to help teams improve performance and manage risk.
BROWSE: All Articles | Audits and Inspections | Quality Management | Regulatory Compliance
How to prevent compliance drift: What a real control management system looks like
A real control management system is a living structure that makes control ownership visible and review deliberate. Audits simply confirm what the organization already knows.
When control review becomes assumption
Compliance programs rarely decay first. What fades first is attention, and with it the consistency of review that keeps controls real rather than assumed.
Why compliance activity doesn’t reduce risk
Compliance activity creates motion, but motion alone does not reduce risk. Real risk reduction happens when controls have clear ownership, consistent review, and purpose beyond the next audit.
Passing an audit doesn’t mean you’re in control
Passing an audit doesn’t prove sustained control. Real stability comes from consistent ownership and control between audits, not from audit readiness alone.
Why evidence-based audits improve year over year
Most audits reset every year. Evidence-based audits don’t. See how structured evidence turns audits into a system for continuous improvement, better visibility, and stronger control performance over time.
How to design an evidence-based audit
Designing better audits isn’t about rewriting questions; it’s about structure. Learn how separating control intent, evaluation, and evidence creates faster, more consistent, and defensible audits.
What is an evidence-based audit?
Learn what evidence-based audits are and why traditional Yes/No audit questions slow you down. Discover how focusing on proof improves audit accuracy, efficiency, and defensibility.
Separating intent from execution: A smarter way to audit risk controls
Risk control audits work best when intent is confirmed before execution is tested. Discover how modern audit tools support clearer findings and stronger quality management.
ASTM’s growing role in global cannabis standards
Global cannabis standards are taking shape now, and the U.S. risks falling behind. This article examines how ASTM International’s D37 standards are becoming foundational to global cannabis compliance, interoperability, and regulatory trust.
How suppliers can move quality upstream
Customer audits don’t have to disrupt operations. Learn how suppliers can move quality upstream by managing controls continuously and reducing audit burden.
Why data security audits must follow risk, not just regulations
Data security audits must follow real risk, not just regulations. Learn why risk-based audits better reflect attacker behavior and evolving threats.
Rethinking HACCP audits through a food pyramid lens
HACCP audits often lose their risk-based focus over time. Refocus food manufacturing audits on real hazards to improve efficiency and strengthen food safety outcomes.
Process problem or people problem? How to find the root cause of issues
When issues repeat, fixing the symptom isn’t enough. Discover how process-focused management uncovers root causes, strengthens accountability, and prevents problems from happening again.
Why 21 CFR Parts 111 & 117 audits take longer than they should
Are cGMP internal audits getting you down? Find out how improving your audit design strategy can make the process more efficient and less cumbersome.
New Year’s resolutions for compliance teams (that actually work)
Improve your compliance audits by integrating compliance into daily work. Compliance by design helps reduce audit stress by integrating best practices in regular work processes, removing some of the burden of stressful audits.
Cannabis businesses: Are you prepared for a compliance audit?
Cannabis businesses should always be ready for regulator and inspector audits. Learn tips on how to be prepared by conducting your own regular internal audits.
Clock is ticking on USDA testing requirement for hemp
After being postponed, the USDA requirement for hemp-testing labs to be registered with the DEA is now on track to take effect December 31, 2025.