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Manufacturers who follow the CGMP regulations such as the pharmaceutical manufacturers need to perform process validation to ensure that all the drugs and medicinal products produced meet the quality standards as defined under 21 CFR 211.100(a) and 2...
In the fast pacing business environments, where document records have grown from hundreds to thousands and millions, the focus of document management has shifted to a large extent. It is not just about the storage and access of the content; it is abo...
An audit is an inevitable part of quality assurance since it helps the organization to verify the best practices at every level. With the regulatory bodies getting more stringent, the audits are now more accountable. The audit findings provide qualit...
Artificial intelligence is changing the way of doing business for every industry, from general manufacturing to the medical cannabis industry. The next generation of technology is all about using data for the effective utilization of the resources wh...
The business landscapes are changing rapidly. The employers need to keep their workforce competent enough to pace up with ever-changing and growing trends. The use of technology has also increased recently, which has become a challenge for many organ...
Whether it’s about the things that we use or the food we consume every day, quality is the prominent consideration. Even the success of the organization depends on the quality of products/services they deliver to their customers. Quality covers a bro...
The disruptive notion of technological advancements has led to many transformations in the business landscape, including some disturbances like skill gaps. It emerged as a challenge for organizations to get their employees trained on requisite skills...
Cloud has been a buzzword for all the industries for the recent few years. Now it has become quite mainstream especially after the Corona hit. Organizations have realized the importance of shifting their processes and operations to cloud applications...
Many organizations consider the change control and implementation the most challenging task to maintain quality. However, change is the only constant. They need a formalized change management system for smoother transitions to the newer technologies,...
With the manufacturing trends shifting to the digital, the paper-based document management process is something left behind. Modern-day manufacturers find digital records a more reliable and safer way to store and retrieve information – be it writing...
Technology has made our lives simpler to the extent that going back doesn’t look like an efficient option. From working in flexible schedules to do shopping on the go, we have different tools, devices, and applications to rely on. One such tool we wi...
It is an undisputed fact that Quality is the number one most important aspect of manufacturing. That’s why you’ll find many quality standards throughout industries and the world. Any industry where more criticality or complexity is involved, the same...
“Customer is King” or “Customer is always right” – all these sayings that organizations used to swear by are fading away. No, this doesn’t imply that you are not serving enough goods and services to your customers. More than the availability of produ...
In the recent few years, there have been drastic transitions in almost every industry including manufacturing, pharmaceuticals, healthcare, and lifesciences due to the intervention of technology especially cloud. Cloud is the one gained high populari...
As the COVID-19 pandemic has outgrown all the numbers forecasted worldwide, it led to the serious implications for the businesses and economy. The existing business continuity plans are not effective either. With the revenues declining all time low, ...
Every organization is embracing the newest technologies to keep the product and process quality intact while maintaining competitiveness. Organizations have now realized the greater need for visibility through the risks to drive quality and continuou...
Since there has been a huge buzz around the term Process Validation, it has become critical to understand the philosophy of this term. Some organizations set some rules to achieve validation. It’s not the right way to go about it. Process Validation ...
Streamline the supply chains has become an essential aspect of every organization. It requires a proper supplier quality management system to attain the strategic goals of a business. However, the approach towards process and risk management may vary...
Being successful for any organization means having the right technology, people, and processes in place. When it comes to technology, organizations now rely on cloud solutions for a smarter way of managing quality. Is it Time to Move to Cloud Solutio...
When it comes to customer retention, the secret lies in the customer experience. Some people often mistakenly consider the quality product as the only component for excellent customer experience. However, it’s just one of the components. The other co...
The Internet is flooded with information on quality management systems. While many of them are genuine resources, there are some circulating inappropriate information, myths, and partially correct information that often misguides people. In fact, peo...
The current COVID19 Crisis has left no industry untouched. It has shaken businesses to their core and drastically changed customer behavior. The novelty of COVID19 virus is complicating the situation, making people think about the implications that l...
While companies are trying to cope up with the quality management principles, process-level improvements is the one that requires continuous efforts. The term process improvement itself implies making processes better and efficient with the time. It ...
Driving continuous improvement in your organization wouldn’t be possible unless you have set some quality objectives. Even ISO 9001:2000 requires an organization to identify and document its quality objectives before heading to process-level improvem...
Whether you call them complicated or the basic guidelines, quality standards are critical for every industry to ensure that they are meeting the minimum requirements. However, these requirements may not always fulfill customer expectations that are g...
The quality and compliance standards are continuously getting stringent for every industry including nutraceuticals. They are not as regulated as the drugs are. They rather fall under different food categories. However, you may find different legal d...
The continuous evolution of technology has led to many innovations and revolutions for the manufacturing industry including the most talked-about one i.e. Industry 4.0. The era of digitization has brought so many exciting changes for the manufacturin...
The increased emphasis on “Quality” has made it mandatory for organizations to have a structured, streamlined, and standardized quality management system that can help them manage all the quality processes while mitigating operational risks. However,...
Any organization to comply with statuary requirements requires a regulated process for document change control especially the ones that belong to the pharmaceutical and medical device industry. These industries need a strategic approach to manage the...
Audit Management Systems are vital for organizations to maintain a culture of continuous improvement while achieving business objectives. There has been a recent upgrade made to the ISO 19011:2018 Guidelines for Audit Management Systems to help organ...