AssurX Blog
Straight talk for regulated industries.
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments
Quality audits are a cornerstone of compliance in FDA and ISO-regulated environments, ensuring that procedures, records, and activities align with stringent regulatory standards. Thes [...]
QMS Validation: How CSA Reduces Documentation Without Increasing Risk
Documentation has long been at the heart of quality management system (QMS) validation, particularly in regulated industries such as pharmaceuticals and medical devices. In environmen [...]
Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking
Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along th [...]
QMS Software: When to Configure and When to Customize
When it comes to managing quality and compliance in today’s regulated industries, selecting the right enterprise QMS software is a strategic decision. Many vendors claim their QMS soft [...]
Why QMS Software Is No Longer Optional in Regulated Industries
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizat [...]
Human Factors in CAPA Part III: How To Secure Management Commitment
In the third and final part of our Human Factors in CAPA series, we’re tackling the big one: management commitment. Why is it so important? Because getting your leaders truly committe [...]
