by tmourit | Apr 3, 2026 | Audits, Quality, Regulatory
In regulated industries, particularly pharmaceuticals, biologics, medical devices, and 503B outsourcing facilities, a gap assessment is not a formality. It is a strategic diagnostic tool. When done correctly, it reveals whether your Quality Management System (QMS)... by tmourit | Mar 27, 2026 | Audits, Quality, Regulatory
Why Are 503B Pharmacies Receiving FDA Warning Letters? 503B outsourcing facilities are registered under Section 503B of the FD&C Act and are required to comply with current Good Manufacturing Practice (CGMP) regulations under 21 CFR Parts 210 and 211. Warning... by tmourit | Feb 6, 2026 | Audits, Quality, Regulatory
Artificial intelligence is rapidly entering quality and regulatory functions across the life sciences industry. From document analysis and gap assessments to trend detection and compliance monitoring, AI offers meaningful efficiency gains. However, in regulated... by tmourit | Jan 30, 2026 | Audits, Quality, Regulatory
The short answer: AI does not replace QA or RA expertise. It reshapes it. When implemented correctly, AI reduces administrative burden, increases visibility, and elevates QA and RA professionals into more strategic, decision driven roles. The Traditional QA and RA... by tmourit | Jan 22, 2026 | Audits, Quality, Regulatory
The U.S. Food and Drug Administration (FDA) is implementing one of the most consequential quality system changes for medical device manufacturers in decades. Effective February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) replaces the long... by tmourit | Jan 9, 2026 | Audits, Quality, Regulatory
As life science organizations face increasing regulatory complexity, many are turning to artificial intelligence to strengthen quality and regulatory compliance. Yet one question consistently rises to the top: How does AI integrate with existing QMS or eQMS platforms...