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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.
The ever-growing and evolving business world, an organization needs to cope with the technological advancements and changes to be successful. More you will be your adaptability; higher will be the chances of success. Hence, change management system has become quite necessary to understand and implement in every organization.
What is Change Management?
Change Management broadly covers the approaches made by organizations to prepare, assist, and support their employees, teams, and even management for making a change – in policies, workflows, processes, etc.
As organizations are going paperless with the adoption of electronic document management systems and record-keeping, the next natural evolution for them is electronic signatures. The norm of digital signatures has offered companies a secure way to verify the authenticity of the electronic records and critical documents.
Let’s start with the fundamentals by going through the definition of the term “Electronic Signatures” and how is it different from the term digital signatures, which people often find confusing.
The medical device industry has witnessed tremendous growth in the past 10-20 years – in terms of revenues as well as the technical complexities of the product. There have been technological evolutions too in the medical device industry, but healthcare professionals still face many obstacles in meeting their goal of delivering quality care within an affordable range of the patients.
The major reason behind the obstacles is inappropriate management of information and device records. It’s high time for healthcare professionals to realize the need for an electronic document management system for maintaining Device Master Record (DMR).