If you want to make the process of change implementation smooth, put fewer efforts, and assist your employees, you must establish a streamlined process that makes the change management easy without facing any resistance.
As we all know that the business environments are changing very rapidly, and effective change management process has become the necessity. There should be effective communication in the organization because it is critical for making a change successful. But nowadays, it has become quite difficult to analyze the right communication approach based on organizational culture.
Do you often feel confused with the usage of terms Nonconformance and Noncompliance? If yes, you are not alone.
Since both the terms are used interchangeably, the confusion is the common outcome. In this post, we will understand the differences between the two, which may initially seem trivial to you. But once you will get to know how these processes work for attaining the goal of product quality, there won’t be a room for confusions anymore.
Modern organizations that want to get maximum returns from the investments need to focus on creating a human capital difference through effective training and development programs for their employees. As they say, the workforce is the most valuable asset for any organization. You should unleash the real potential of this asset to become a great organization from a good one.
The organizations who have already invested in advanced training solutions tend to achieve both short- and long-term business objectives since their employee engagement rate has significantly increased. Even the employees nowadays understand the need for continuous skill improvement and learning to be competent. This is the reason training has become the buzz word in nearly every industry.
Designing a product that serves its intended purpose is critical for medical device manufacturers, as it could have a great impact on a person’s health- for that matter even life. You can still manage your tasks if your internet modem is not working as it should be, but can you manage to breathe if your inhaler is insufficient to provide you the medication when you are already struggling to breathe. The worst scenario here could be a risk to your life, which is not acceptable at all.
Credit goes to the technology advancements, the medical industry has better and improved solutions to sustain lives and offer quality care like never before. When a nonconformance is identified in a medical device, it needs urgent attention. You need to investigate its root cause, resolve the issue as soon as possible, and most importantly, prevent its recurrence in the near future. You must have an effective CAPA process or CAPA management software to ensure timely correction or prevention of the product issues that may have frightening consequences.
In the era of digitization, every industry is experiencing transformations more than they ever expected including the highly regulated industries including healthcare and lifecsiences. It cannot be denied that such industries need to adopt the next-generation quality management systems to assist the critical quality processes and procedures since customers are aware and concerned for quality products more than ever. Attaining quality is not important with respect to customer expectations, but also to comply with the compliance and regulatory requirements.
In the quality domain, it’s a common belief that sooner a nonconformance gets identified and resolved, lesser will be its impact. The advent of technology and cloud-based solution for quality management have made this belief even more actionable. The quality professionals can now have deeper insights and can make informed decisions with the use of closed-loop quality management system.
Especially when the next-generation solutions are making their way at such a faster pace – from designing, manufacturing, distribution, and marketing – industry leaders prefer to bring together the prominent data resources and systems that can form a closed-loop quality process between the key processes and the teams.
With such closed-loop processes, you can facilitate improvements in the existing quality management system for driving continuous improvement while reducing the overall quality issues and costs. Let’s first understand the term quality management system and closed-loop quality management in detail before moving to the discussion on its significance.
With the increasing popularity of analytics and big data, business owners are becoming aware of the significant role that data management plays for an organization. Credit goes to factors like forecasting customer expectations, product management, availability, improved customer services, and competitor’s analysis, data quality management is a critical function for any organization.
One important condition applicable here is that the data should be complete, accurate, and consistent to help businesses make informed decisions. It won’t be wrong to say that modern businesses cannot afford to ignore data quality management.
CAPA is often the most discussed topic among all the aspects of the closed-loop quality management system due to the critical role it plays. Still, companies face difficulty in implementing it right and feel frightened by the thoughts of regulatory audits. Such difficulties often come as a surprise in the highly advanced technological era when companies have access to cutting-edge CAPA management software.
In fact, the CAPA process is becoming one of the challenging aspects for the organizations as the time passes by and the regulatory standards getting stringent. This results in immense pressure on the companies to follow best practices, which further leads to certain mistakes that they don’t even realize.
Lifesciences industry is undergoing a huge digital transformation wherein they are adopting newer and smarter technologies for attaining operational excellence. The best thing about the digital transformation is the evolution of quality management solution for the Lifesciences industry that serves the intended purpose of improving product and process quality quite effectively.
However, there are still many Lifesciences companies struggling with quality management and manufacturing challenges. Let’s have a deeper understanding of the challenges before discussing their resolution.
With the evolution of the combination products developed by medical device manufacturers and pharmaceutical companies in partnership, the need for a robust quality management system is accelerated.
In an effort to improve health and safety for the patients, the healthcare industry has introduced combination products. The objective is to create and deliver safe products that can fulfill customer needs for quality healthcare. Many new therapies are researched and tested for a range of diseases, which are further administered in many new ways.
These new ways are about combining drugs, biological product/devices, and medical devices for minimizing the adverse events while making a significant improvement in treatments and user experiences.