Analytical labs play a central role in drug development and manufacturing. Whether testing raw materials, finished products, or environmental samples, the accuracy and integrity of lab data are vital for patient safety and regulatory compliance. That
Is ISO 9001:2015 Legally Required? Understanding Its Role in Regulatory Compliance
ISO 9001:2015 is one of the world’s most recognized quality management standards. It helps organizations build reliable systems, improve consistency, and meet customer expectations. But a common question still comes up: Is ISO 9001 legally required?T
Ensuring QMS Compliance During Holiday Downtime: A Guide for Medical Device Teams
The holiday season can be a peaceful break for many, but for medical device companies, it can create challenges for maintaining compliance. With operations slowing, key staff taking time off, and regular routines being disrupted, staying aligned with
How to Implement a QMS for Medical Devices: A Step-by-Step ISO 13485 Guide for Compliance
ISO 13485 Medical Device QMS Guide /* Base adjustments that complement inline styles */ :root { --text: #2a2a2a; --muted: #374; --brand: #24667a; } body { color: var(--text); } header p,
Hazard Communication in FDA Workplaces: A Role-Based Overview
:root{ --ink:#22323d; --muted:#475569; --brand:#2a6e86; --bg:#f7fafc; --softA:#eaf4ff; --softB:#f1fbf7; --card:#ffffff; --shadow:0 12px 26px rgba(42,110,134,.10); --shadowHi:0 18px 38px rgba(
Avoid These Common Mistakes in Process Validation
/* ---------- Theme Tokens ---------- */ #gmp-sections{ --ink:#0f2e2a; --muted:#2a4e46; --accent:#19c37d; --accent2:#3aa0ff; --ring:rgba(25,195,125,.18); --bg1:#f6fffb; --bg2:#eef7ff; --card:rgba(255,255,255,.86); --shadow:0