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FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 o [...]
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 [...]
