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).
Quality is, indeed, a broader aspect to understand than what it sounds. Quality Assurance, Quality Control, and Quality Management are commonly used terminologies by organizations with respect to the quality of their products and services. However, implementing a quality management software simplifies the quality operations for every industry.
But what’s the difference between the terminologies?
This post will help you understand each of them in detail. Let’s quickly start with their definitions:
It basically refers to the section of quality management that ensures the quality requirements are fulfilled – in compliance with regulatory standards as well as customer expectations. Alternatively, we can define quality assurance as a planned and systematic implementation of certain activities required to fulfil quality requirements, building trust for the brand among the potential as well as existing customers without fail.
Yet another feather added to our success cap with the announcement of “The 10 Recommended Audit Management Solution Providers 2019” by Insights Success.
We feel immense pleasure to share that Qualityze tops the list of 10 Recommended Audit Management Solution Providers 2019. Read More
Our commitment to driving excellence through our products and services keeps us motivated for developing innovative quality management solutions for our customers. Our solution range is the perfect fit for the business owners who are looking to create, manage and scale up the “Culture of Quality”.
The organizations today are taking steps for continuous improvement of quality in their products and services to meet customer requirements and compliance standards simultaneously. The focus on continual improvement helps them to drive operational excellence while mitigating risks.
Making a holistic approach towards the organization’s operational excellence requires two aspects in the first place: Quality Management and Risk Management. Both aspects play a significant role for businesses to attain their quality goals. You can bring them together for a successful implementation of the quality management system in your organization.
In fact, quality management and risk management are often referred to as the two sides of the same coin. Let’s quickly have the definitions of Quality Management and Risk Management before further discussion:
Building a culture of quality depends on reactive and proactive functions, processes, and workflows in the organization. However, the best approach to attain quality has always been debatable. In this post, we will look at the pros and cons of both reactive and proactive approach towards the quality issues to identify which one is better for quality management.
Though most of the companies today are equipped with advanced quality management systems; still only some of them are striving with excellence while others are still struggling for effective management of their quality issues. The only difference is their approach – some of them are leaning ahead with proactive approach while others are still relying on the reactive one.
Before any further arguments, let’s just understand both the approaches in depth. It will help you have a clear choice of approach you should take your business ahead with.
Qualityze is all set for ASQ 2019 World Conference on Quality and Improvement and looking forward to catching up with the Quality Enthusiasts and guide them with the right QMS solution based on their business needs.