BLOG
Life Sciences
Tips for Preparing for an ISO Certification Audit
Recent ISO data shows a growing number of certificates being issued across all standards. A notable increase is especial [...]
An Overview of the FDA Draft of CSA Guidance for Quality Systems
In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation req [...]
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, an [...]
Root Cause Analysis Tools: Which Should You Use?
Root cause analysis is a common weak spot in manufacturing, causing numerous quality issues, product safety problems, an [...]
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufacturers. It applies equally to animal foo [...]
How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge for device manufacturers struggling with M [...]
