Types of Quality Control in Pharmaceutical Industry
Quality professionals know the feeling: one overlooked specification, and suddenly the FDA dashboard becomes the focal point of the night. It might be difficult to believe for those who haven’t really faced it. But it is good to be aware of things th...
Manufacturing Inspection & Quality Control
Every finished part that rolls off a line carries your company name—and the weight of global regulations behind it. Whether you build micro-valves for pacemakers or chassis parts for EVs, authorities such as ISO (ISO 9001:2015), the U.S. FDA (21 CFR ...
How eCRF in Clinical Trials Improves Compliance
eCRF in clinical trials has revolutionized how data is collected, validated, and submitted. This guide explains its features, benefits, and role in regulatory compliance. Learn the difference from paper CRFs, explore best practices, and see how Quali...
Cloud Document Management System with AI
In today’s fast-moving digital world, businesses are flooded with documents—policies, procedures, records, and more. Managing all of that manually or with outdated systems? That’s a recipe for chaos. The good news? There’s a better way: A cloud-base...
CAPA for Medical Devices: Ensure Compliance and Quality
Quality issues in medical devices are rarely isolated from events- rather they are often signals of deeper system vulnerabilities. That is the primary reason that CAPA for medical devices industry has transformed from a reactive process to a strategi...
ISO 14971: Risk Management Guide for Medical Devices
Medical devices significantly impact patient care, directly influencing health outcomes and quality of life. However, these devices inherently carry risks, which can result in harm if not effectively managed. To address this critical issue, ISO 14971...
ISO 9001 Quality Management Principles You Must Know
Coffee machines that never leak, airplanes that land on time, and cloud apps that stay online – all three share a common backbone: a documented, continuously improving quality management system (QMS). ISO 9001 is the global rulebook for that backbone...
ISO 9001 Clause 8.5.2 Identification & Traceability
Organizations across quality-focused business environments face increasing pressure to deliver consistently reliable and safe products. Meeting customer expectations and regulatory requirements is no longer optional—it’s critical to maintaining reput...
Medical Device Quality Assurance for Regulatory Compliance
In March 2025 the FDA stamped Boston Scientific’s Accolade pacemaker recall as Class I—the most serious category—after linking battery failures to 832 injuries and two deaths. Only months earlier the agency renewed pressure on Philips to finish repai...
Types of Batch Records in Pharmaceutical Industry
Every batch of tablets, vials, or capsules you see on the market comes with a paper—or increasingly digital—trail that tells its entire production story. These “batch records” document every step, from weighing raw materials to final packaging, so re...
Quality Management in Healthcare: Importance & Purpose
Imagine walking into a hospital where everything runs seamlessly: minimal waiting times, clear communication, safe procedures, and a reassuring environment that puts your mind at ease. This isn't just luck—it's the result of effective quality managem...
Supply Chain Quality and Compliance: Key Importance
Supply chains are the backbone of today’s global economy—but as they grow more complex, so do the risks and expectations that come with them. From pharmaceutical ingredients sourced overseas to electronic parts shipped across continents, organization...
Quality Control and Quality Assurance in Healthcare
Every year, billions worldwide rely on healthcare systems for everything from routine check-ups to life-saving surgeries. Global healthcare spending reached an estimated $9.1 trillion in 2022, highlighting the immense scale of this critical sector. Y...
ISO 15189 for Medical Laboratory: Purpose and Benefits
When you visit a doctor and get lab tests, the accuracy of those results isn’t just important—it’s crucial. Imagine a medical laboratory operating without clear quality standards; results could be inconsistent or incorrect, leading to improper treatm...
Job Safety Analysis for Better Hazard Identification
Organizations with a mature safety culture understand that Job Safety Analysis (JSA) is not just a documentation activity, but rather a powerful tool to embed hazard awareness into every job function. JSAs deconstruct tasks, identify latent risks, an...
Intended Use and Indications of Use: Key Differences
One poorly chosen verb in a product label can land you into an FDA “refuse-to-accept” letter, a re-run of clinical studies, and months of lost revenue. Clear Intended Use (IU) and Indications for Use (IFU) statements are the guard-rails that prevent ...
ICH E6 R3 Good Clinical Practice (GCP): Key Updates
ICH E6 R3 demands that critical-to-quality risks, digital data flows, and consent clarity are baked in — not patched later. Sponsors ready to pivot now will slash deviations, monitoring costs, and submission cycles. Those who wait will write amendmen...
Design Verification and Validation: Process and Compliance
For medical device, pharma, or biotech companies, product design is not an engineering exercise, but a compliance journey. Design verification and validation (V&V) are the important milestones in the journey, basing your development strategy in both ...
Supplier Corrective Action Request: What You Need to Know
Have you ever received a faulty component from a supplier and wondered how to fix and prevent it from happening again? Is your supply chain dependable? Do you have full control over the quality of components and services you receive from external ven...
Quality Metrics in a Pharmaceutical QMS
Under comprehensive GMP regulations, only a well-built QMS can assure consistent drug safety and quality. Think of your QMS as a structured network of policies, processes, and procedures designed to consistently ensure that medications are safe, effe...
510k vs PMA Medical Device Approvals
Have you ever used a medical device? If you are an adult, chances are high that you must have used one, whether invasive or non-invasive. Medical devices are a part of our modern life. But how many of us pause to think about the process behind bringi...
Non-Conformances in Quality Management: Key Insights
How much does preventing quality failures truly matter? It matters immensely. Preventing non-conformances in quality management is indispensable to any organization’s operational excellence and sustained success. These deviations from specified requi...
IEC 62304 Role in Medical Device Compliance
IEC 62304 is an international standard that defines the life cycle requirements for medical device software. It provides a framework for developing and maintaining software used in medical devices, ensuring safety and effectiveness throughout the sof...
Quality Investigation Report: Purpose and Best Practices
A quality investigation report is a formal document that narrates the step-by-step inquiry into a specific quality event—whether that event is a nonconformance, customer complaint, process deviation, or audit observation. At its core, the report aims...
Guidelines for Investigation in Pharma Industry
In the pharmaceutical industry, even minor anomalies aren’t just warning signs—they become immediate triggers for compliance action demanding a swift structured investigation. When human health is on the line, there’s absolutely no room for error. Ev...
Understanding Class III Medical Devices
When it comes to medical devices, not all risks are created equal. Class III devices sit at the top of the risk ladder—they’re the ones that sustain or support life, or pose a potentially serious risk of illness or injury if they fail. Think of the t...
Understanding EU MDR Medical Device Classification Rules
The EU MDR medical device classification system has its roots in Regulation (EU) 2017/745, which fundamentally redefines how medical devices are regulated throughout the European Union. Replacing the previous MDD (Medical Devices Directive), EU MDR i...
Electronic Document and Record Management System
An Electronic Document And Record Management System empowers organizations to manage critical documents with traceability, digital document control, and compliance built-in. Learn how to choose the right solution and reduce audit stress.
8D in CAPA: Everything You Need to Know
Wondering what is 8D in CAPA investigations? Learn how this structured method helps uncover root causes, prevent recurrence, and ensure compliance.
FDA Cleared vs Approved vs Granted: Key Differences
Have you ever wondered about the differences between “FDA cleared," “FDA approved,” and “FDA granted” when it comes to medical products? Understanding these distinctions is crucial whether you are a patient, a healthcare professional, or a manufactur...
