To remain compliant, any organization within the life sciences sector must undertake audits. This process involves investigating, verifying, and reviewing activities related to producing and distributing products. Auditors look at everything from suppliers to manufacturing processes to documentation.
Manufacturing is huge, complex, and changing quickly. Manufacturer success lies in staying on top of ever-evolving trends and continuing to innovate. Explore the role of competitive pressure, changing demand, and timing in manufacturing, plus five manufacturing trends you need to know.
Severe financial penalties and legal headaches await medical manufacturers who fail to meet the FDA's MedWatch reporting requirements. Not to mention the downfall of your brand value. Our guide prepares you with best practices to simplify and streamline MedWatch reporting and achieve compliance at scale.
Don't get lost in the jargon! By understanding global harmonization vs. standardization and which is right for your business, you're on the right path to optimal quality no matter how complex your manufacturing environment is.
The cost of poor quality (COPQ) is an important consideration for any food and beverage company looking to operate safely and efficiently. Still, care must be taken to ensure the cost of good quality isn't also sacrificed.
Discover Industry 4.0's impact on quality management through the empowered connected worker. CTO John Taylor reveals how digital tools like ETQ Reliance optimize manufacturing processes and decision-making.
A ruling has been made! After a long wait, the Food and Drug Administration (FDA) finally published its Quality Management System Regulation (QMSR) in February. While not effective until February 2026, the ruling ensures regulatory consistency for medical device manufacturers.
Food and beverage companies perform a delicate balancing act. Their goal is to lower the overall cost of poor quality. They want to achieve this while avoiding any compromises that might lead to increased waste, product recalls, or damage to their reputation. A quality management system (QMS) can help businesses achieve that balance.
Current Good Manufacturing Practices (cGMP) guidelines set forth essential standards for manufacturing processes. Following these guidelines helps ensure product quality and safety while boosting compliance within regulated industries.
Frontline workers are the backbone of the manufacturing industry. Increasingly, they are using devices such as mobile devices, wearables or apps to stay connected to the manufacturing process in real time and perform their roles more effectively.
The Occupational Safety and Health Administration (OSHA) requires formal hazard assessments for situations such as confined space work or when a job calls for Personal Protective Equipment (PPE). Conducting a Job Safety Analysis (JSA) is one way to meet these requirements, and to make any dangerous job less risky.
It is important for manufacturers to use Supplier Corrective Action Report (SCAR) to improve supplier quality. Learn how in this blog.
