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Introduction: The Invisible Wall – When Compliance Isn’t Enough A GxP auditor’s job is to ensure compliance, to verify that a Quality Management System (QMS) is meticulously followed. We are trained to spot deviations, review records, and check boxes. We operate within the Project Management Triangle where time, cost, and quality are in constant tension. […]

In the rapidly evolving landscape of life sciences, leadership matters more than ever. As a CEO navigating the intricate world of quality assurance, I’ve come to deeply appreciate the diverse strengths that effective leaders bring to the table. Among these, the contributions of women in leadership roles stand out as a transformative force—not just in

As members of the marketing and business development team, we recognize the transformative role quality assurance (QA) plays in the pharmaceutical industry. QA is at the core of patient safety, regulatory compliance, and innovation—essential for maintaining trust in healthcare products. With the increasing complexity of global regulations and emerging technologies, the QA industry presents exciting

The pharmaceutical industry operates under strict regulatory frameworks to ensure the safety and efficacy of medicinal products. Managing the Cost of Quality (CoQ) is essential for balancing financial performance with compliance. CoQ includes prevention, appraisal, internal failure, and external failure costs, each playing a critical role in quality management. Categories of CoQ: Prevention Costs: Investments

Bioanalysis is a key component in the trialling of any investigational medicinal product (IMP) and generates the pharmacokinetic, toxicokinetic, and bioavailability/bioequivalence data used for new drug application (NDA) submissions. Accurate and precise bioanalytical methods ensure the integrity of clinical and non-clinical data. Therefore, the data generated from bioanalytical studies safeguards patient safety and drug efficiency.

My month-long internship at RiverArk represented far more than a simple work experience; it marked a pivotal moment in my personal and professional development. Coinciding with my twentieth birthday, this opportunity served as a meaningful transition into both adulthood and the professional world. It felt very symbolic in its own way. I felt as if

Being the first person to ever do work experience at RiverArk was a unique and memorable opportunity. Although the placement was virtual and only lasted a week—from March 3rd to 7th, 2025—it gave me deep insight into the values, mission, and day-to-day operations of a community-focused organisation. I felt proud to represent not only myself

In a significant move toward digital transformation, on 02 Jun 2025 the U.S. Food and Drug Administration (FDA) unveiled a new generative AI tool named Elsa, designed to enhance operational efficiency across the agency, including streamlining scientific reviews. FDA Commissioner Marty Makary praised the early and cost-effective rollout, stating, “Today’s rollout of Elsa is ahead

In the digital age, maintaining data integrity is essential, especially in the pharmaceutical industry, where regulatory compliance is critical. The ALCOA+ principles—Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available—offer a framework for data integrity, also applicable to digital systems. Each principle emphasises precise documentation, accurate record-keeping, and secure, accessible storage.   Key Challenges in

There’s a phrase in EU GMP Volume 4 that was a pleasant surprise the first time I read it. It struck me as a very good idea, and I wondered why other GxPs hadn’t done something similar. From Part 1, Chapter 4: “The various types of documents used should be fully defined in the manufacturer’s