Straight talk for regulated industries.
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 requirements for medical device manufacturers. The guidance signifi [...]
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. Th [...]
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, and enforcement actions. For example, recent headlines over baby f [...]
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 food manufacturers. Recently, the FDA released updates for animal f [...]
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 Medical Device Regulation (MDR) compliance. As a result, the EU’s [...]
8 CAPA KPIs You Should Be Measuring Now
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, trac [...]