Qualityze - Blogs
The US FDA Quality Plan: Critical Elements for Success
Let’s talk about Compliance. No, not the dull, paperwork-heavy, “check-the-box” kind of Compliance. We mean absolute Compliance—preventing warning letters, recalls, and million-dollar penalties while making your operations smoother, faster, and more ...
Medical Device Complaints: Mistakes and How to Fix Them
Medical device complaints can be a goldmine of insights—or a regulatory nightmare. Let’s be honest—regulators take medical device complaints very seriously. The FDA’s 21 CFR 820.198 and ISO 13485:2016 set strict expectations for complaint handling...
Nonconformance Software Implementation: A Complete Guide
Imagine running a busy restaurant. If one ingredient is subpar, it throws off the whole dish—and customers will notice. The same goes for business processes: when something falls out of line, it can lead to quality issues, frustrated customers, and e...
How Often Should You Do a Supplier Quality Audit
Ensuring a Resilient, Compliant, and Future-Ready Supply Chain Imagine you open your inbox to find yet another supplier quality audit report. Your heart races—not out of fear, but because you know that every detail uncovered today is a safeguard f...
Is Automated Quality Management Right for Your Business?
In an age where 65% of consumers will leave after a poor experience, Automated Quality Management isn’t just a “nice to have”—it’s becoming essential for businesses aiming to stay competitive, deliver consistent customer service, and streamline compl...
QMS Audits in Regulated Industries
When you work in a regulated industry, follow best practices day in and day out, and have all your compliance documentation in place, nothing really bothers you. Then comes your audit reminder; just like that, the air thickens with apprehension. ...
Quality Strategy in Regulated Industry 2025
You know what’s worse than an FDA warning letter? Finding out about it on the news before your own team tells you. Sounds dramatic? It happens more often than you’d think. Take the case of a well-known pharmaceutical giant (We won’t name ...
Pre-Determined Change Control Plan: A 21 CFR Part 820 Guide
The medical device industry isn’t what it used to be. It’s faster, riskier, and more AI-driven than ever. We’re not just tweaking hardware anymore—we’re talking self-learning algorithms, automated diagnostics, and machine-learning models that evolve ...
Automate Training Management for Compliance Success
Did you know that training costs businesses $13.5 million per 1,000 employees each year? Yet 74% of workers believe they are not reaching their full potential due to a lack of development opportunities. Most corporate training programs fail, with ...
How to Use AI For Efficient Cloud Document Management?
Research indicates that ineffective cloud document management can cause companies to lose approximately 21% of their productivity due to time wasted searching for documents. This results in substantial financial losses from unproductive work hours an...
Pharmaceutical Quality Control Basics
Ever taken a pill and simply trusted it would do its job? There’s a reason for that confidence, and it’s not just blind faith. Behind every tablet, capsule, or vial lies a network of rigorous checks and balances called pharmaceutical quality cont...
Top Reasons CAPA Plans Fail and How to Fix Them
Did you know most FDA Form 483 observations are due to CAPA failures? For companies in regulated industries, a weak CAPA plan can mean more than just fines. It can lead to product recalls, inefficiencies, and a damaged reputation. In 2016, a le...
How to Identify Nonconformities in Your ISO 9001 System
Talking about quality management for medical devices in 2025 – you cannot afford to miss the role of AI in making quality processes better, simpler, and smarter. Before we move on to discuss technological advancements, we must ensure we are not m...
Reasons to Invest in an EHS Management System Right Now
An Environmental, Health, and Safety (EHS) management system is a structured framework organizations use to manage environmental responsibilities, workplace safety, and employee health. It combines policies, procedures, and tools to ensure safety and...
How Quality 4.0 can Boost Your Business
The business world is in flux. It is witnessing daily disruptions, and the future is more uncertain than any time before. The success of a business today depends on its flexibility and adaptability to technological changes. Businesses turn to Quality...
Future Trends in Inspection Management
Inspection management is non-negotiable in product quality, safety, and industry compliance. As technology evolves, inspection processes become smarter, faster, and more efficient. Businesses must adapt to these changes to remain competitive and comp...
The 5 Why's and 5 How's: Discover the future of RCA
The 5 Whys and 5 Hows method is a structured approach to problem-solving. It helps identify root causes and implement practical solutions. Developed by Sakichi Toyoda, the method became popular in Toyota's manufacturing processes. Its simplicity and ...
Mastering Quality Checklists: Your Ultimate Guide to Success
Quality defines a successful business. It ensures that products, services, and operations meet customer expectations and regulatory standards. One of the most effective tools to manage quality is the quality checklist. These checklists provide a syst...
Current Good Manufacturing Practices (cGMP) Role in Quality
Quality in Manufacturing is critical. It assumes critical significance, especially when producing products that impact public health and safety. Current Good Manufacturing Practices (hereinafter cGMP) are essential in ensuring that products meet high...
Best Change Management Practices for Manufacturing
How often have you heard the "Change is the only constant" adage? Cast a cursory glance around yourself, and you will find most things are ephemeral. Some changes are good, while some could bring challenges. One must develop an ability to foresee the...
Training Management Software for Life Sciences
The life sciences industry is complex, highly regulated, and rapidly evolving. Businesses must consistently train employees to meet regulatory requirements and technological advancements. Training management software simplifies the process. It helps ...
Role of Audit Management Software: From Compliance to Performance
The business landscape is becoming increasingly dynamic worldwide. Companies must navigate ever-evolving regulatory standards and practices to ensure operations are compliant and effective. Compliance and performance audits have become essential for ...
Benefits of AI-Powered CAPA
For manufacturers in industries like automotive, aerospace, electronics, and medical devices, effective quality management is crucial to staying competitive. These industries explicitly deal with complex products, and the market evolves rapidly, maki...
Best Practices to Manage Manufacturing Non-Conformances
A non-conformance is a deviation from your specified requirement. It means a product or process doesn't meet your quality standards. Violation of quality standards could range from minor issues like a missing label to major defects that compromise sa...
Why HL7 Protocol Matters for Your Healthcare Industry?
Health Level 7 (hereinafter HL7) is a set of international standards for transferring patient data between software applications used by various healthcare providers. It ensures seamless communication and data exchange, improving efficiency and accur...
5 Steps to Master QMS Audit Preparation
A Quality Management System (hereinafter QMS) audit is essential for any organization that wants to ensure its products and services meet the highest quality standards. It is a systematic examination of an organization's QMS to identify areas for imp...
Recalls Up 8% in Q1 as Product Safety Recall Oversight Grows
Product recalls have become a significant concern for consumers and businesses alike. In recent years, the frequency and severity of recalls have increased, prompting regulators to take more stringent measures to ensure product safety. In the first q...
QMS Audit: Types and its importance
The post-pandemic business world is markedly different from the pre-pandemic one. Regulatory bodies have evolved and become more stringent, and companies face increasing scrutiny over quality, safety, and compliance today. Maintaining high standards ...
Guide to FDA eMDR - Electronic Medical Device Reporting
The healthcare industry has seen rapid advancements, particularly in medical devices. However, with this growth comes the need for strict regulations to ensure patient safety. One such regulation is the FDA's Electronic Medical Device Reporting (eMDR...
FDA Change Management Plan: A Guide You Need
Without a structured change management plan, even the smallest tweaks can lead to massive headaches—regulatory fines, supply chain disruptions, or, worse, product recalls. Change is inevitable, but how you manage it determines your ability to stay co...
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