The Role of QMS in Maintenance Management Software
Quality and maintenance management go hand in hand, especially in highly regulated industries. A Quality Management System (QMS) provides the framework of policies and procedures to ensure products meet safety and efficacy standards. On the other han...
Why Your Calibration Process Needs a Modern Makeover?
Approximately 50–80% of equipment may be non-functional due to poor calibration management - as studies by ResearchGate suggest.
In fact, almost one in five FDA warning letters pointed to calibration issues.
What does this mean for you?
Y...
Quality Risk Management in Pharmaceutical Industry
Quality risk management in pharmaceuticals is a key to regulatory adherence and business continuity. Learn how integrated risk management software improves risk assessment, compliance, and operational efficiency for a seamless risk management approac...
Benefits and ROI of QMS Software
Quality Management Systems (QMS) are formal frameworks of processes and procedures aimed at ensuring product quality, safety, and regulatory compliance across organizations. Originally rooted in manufacturing, QMS principles are now applied in virtua...
How to Master Pharmaceutical Quality Assurance
Pharmaceutical Quality Assurance (QA) plays a critical role in the health and safety of consumers. Maintaining product quality has become increasingly challenging as the pharmaceutical industry continues to grow. Poor pharmaceutical QA can have sever...
The New Age of CAPA In Pharmaceutical Industry
Regulatory agencies demand more than just corrections. CAPA in Pharma must evolve with real-time monitoring and automation. Discover next-gen CAPA Management in Pharma solutions. Stay ahead of regulations. Learn more today!
Complaint Management for Medical Devices Made Easy
Handling complaints of medical devices is essential for maintaining compliance with FDA and ISO standards. Is your organization implementing the best practices?
Customer complaints are inevitable for any business enterprise. The medical science i...
What is EHS and Why is it Important? Best Guide
EHS (Environment, Health, and Safety) might not be the flashiest topic, but it’s the unsung hero of every thriving business. Think of it as the ultimate insurance policy—except instead of protecting your car, it safeguards your people, your reputatio...
What Is Quality Risk Management And Why Is It Important
Ever lie awake at night stressing about product recalls, audits, or that nagging feeling you’ve missed a critical step in compliance? If you’re a quality manager, compliance officer, or manufacturing lead, we get it. The daily grind of meeting regula...
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...
