by tmourit | Aug 6, 2026 | Audits, Quality
A quality system can appear complete on paper and still fail during an audit or regulatory inspection. The problem is often not that a company lacks procedures. The problem is that its procedures, records, training documentation, and actual practices do not... by tmourit | Jun 12, 2026 | Audits, Quality
Corrective and Preventive Action (CAPA) is one of the most important elements of a quality management system. Regulators and auditors view CAPA as evidence of an organization’s ability to identify issues, investigate root causes, implement corrective actions,... by tmourit | Jun 5, 2026 | Audits, Quality
FDA inspections are a critical part of ensuring life science companies maintain compliance with applicable regulations and quality system requirements. Whether your organization operates in the medical device, pharmaceutical, biotechnology, diagnostic, or clinical... by tmourit | May 29, 2026 | Audits, Quality
Understanding FDA 483 Observations An FDA Form 483 is issued when an FDA investigator identifies conditions that may violate the Food Drug and Cosmetic Act or related regulations during an inspection. Receiving a 483 does not automatically mean a company will receive... by tmourit | May 15, 2026 | Audits, Quality
What should we expect during an FDA inspection? FDA inspections are structured but can vary depending on the product type, facility, and inspection scope. Typically, inspectors will: • Review your Quality Management System (QMS) • Assess compliance with applicable... by tmourit | May 6, 2026 | Audits, Quality
Under ISO 13485, organizations are expected to apply controls to suppliers, contractors, and consultants based on the effect their products or services can have on the quality of the medical device. That sounds straightforward in theory. In practice, many companies...