Quality Assurance
At Apotech, we have worked with a
huge range of clients all around the world.
With consultants and teams present in 30 key life science markets, we have successfully executed projects in over 110 countries and helped a large number of innovative medical devices and products enter the market with complete regulatory compliance.
Keep reading to discover some of our most recent case studies.
10 CAPA Metrics and KPIs Every Quality Team Should Track
By Imane Nohair, GxP Audit manager at Apotech Corrective and Preventive Actions (CAPAs) are a fundamental element of quality management across the pharmaceutical & biotechnology industries. When designed and executed effectively, CAPAs do more than address isolated non-conformities. CAPA processes strengthen quality systems, reduce regulatory risk, and support sustained compliance across global regulatory frameworks. Across…
From Audit Non-Conformities to CAPA: A Systematic Approach
By Imane Nohair, GxP Audit manager at Apotech An organized method from audit non-conformities to CAPA overview is key for operational efficiency and compliance in the pharmaceutical industry. Continuous improvement, product quality, and long-term compliance can be assured when these non-conformities are successfully addressed through a Corrective and Preventive Action (CAPA) procedure. This article describes…
How to Make Sure Your CAPA Process Actually Works?
By Imane Nohair, GxP Audit manager at Apotech If you work in quality management, you know how important the CAPA (Corrective and Preventive Action) process is. It helps identifying problems, fixing them, and preventing them from happening again. But here’s the real challenge: how do you make sure those fixes actually work? Many companies put…
2024 Pharmaceutical Inspections: Risk-Based, Remote-Ready, and Globally Harmonized
Staying audit-ready is no longer optional, it’s strategic! Based on EFPIA’s 2024 Inspection Survey, pharmaceutical manufacturers must align with increasingly global and risk-based inspection models. At Apotech, we help clients confidently meet these evolving expectations. Inspection compliance is consistent: no matter the type Whether a Pre-Approval Inspection (PAI), routine check, for-cause investigation, or surveillance audit,…
ALCOA+ Principles in Pharma: The Next-Gen Standard for Data Integrity
ALCOA+ and the modern data integrity landscape Data integrity underpins regulatory compliance and patient safety. And as pharmaceutical and biotech organizations adopt increasingly digital systems, automated workflows, and globalized supply chains, regulators including the FDA, EMA, and MHRA have intensified their focus on how data is generated, captured, and maintained. The ALCOA+ principles form the…
What is QMSR vs QSR? Understanding The FDA Final Rule and ISO 13485 Harmonization
The Quality Management System Regulation (QMSR) is the U.S. Food and Drug Administration’s (FDA) new rule replacing the Quality System Regulation (QSR) for medical devices. Finalized in February 2024, QMSR updates 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, aligning U.S. quality system requirements with the internationally recognized medical device standard while retaining certain FDA-specific obligations. The…
How To Master The CAPA Process Step-by-Step: From Identification to Implementation
The Corrective and Preventive Action (CAPA) process is a core mechanism within Pharmaceutical and Biotech quality systems, designed to identify, address, and prevent issues that may impact compliance, product quality, and most importantly, patient safety. In regulated environments, CAPAs are not isolated actions but structured responses embedded within a wider quality management framework. CAPAs are commonly triggered by internal…
Finding the Right Quality Assurance (QA) Consultants in Life Sciences
Written by Connie Prince – Talent Acquisition Manager Life sciences organizations increasingly rely on Quality Assurance (QA) consultants to support complex regulatory, operational, and quality system requirements across the product lifecycle. As companies scale, diversify supply chains, and operate across multiple regions, maintaining effective and proportionate GxP quality systems requires both depth of expertise and…
FDA Mock Inspections: Types, Common Findings and How to Prepare
Not every FDA mock inspection looks the same. The discipline a regulator will scrutinize, and the questions your team needs to answer, depend on where your product sits in its development journey. A clinical-stage biotech preparing for a BIMO mock inspection faces very different challenges from a commercial manufacturer rehearsing a GMP inspection. Choosing the…
QSIT vs QMSR: FDA’s New Medical Device Inspection Framework Explained
For more than two decades, the Quality System Inspection Technique – known universally in the medical device industry as QSIT – defined how FDA investigators approached inspections of device manufacturers under 21 CFR Part 820. That era ended on February 2, 2026. On that date, the FDA’s new Quality Management System Regulation (QMSR) came into…
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