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Essentials of Quality Management for Life Sciences Industry

Jan 12, 2022 12:40:02 PM

A quality management system  is essential to the success of the life sciences industry. However, meeting business goals requires quality regulatory compliance for continuous improvement and safety assurance of products.

While profit-making is the goal of most businesses, life sciences enterprises focus on saving lives. The life science industry must comply with several regulatory requirements to design and manufacture safe and quality products.Therefore, every life science enterprise must cross the hurdles of maintaining quality regulatory compliance, improving production performance and offering modern and quality products to the market. The dynamism of the compliance requirements and adaptability is more challenging.

Why is Maintaining Product Quality Important?


Today's business environment is filled with informed customers who understand the industry and precisely what they want. The internet has made it possible for clients to interact with numerous suppliers simultaneously. Similarly, the advancement in logistics has made it possible to deliver products easily.

Medical appliances and other life sciences products must meet a water-tight quality compliance process, and the ability to achieve this ensures profitability and peace of mind. That said, there is a need to reemphasize the importance of compliance. Compliance solutions for life sciences will help achieve safer products for the environment and the users while also facilitating stress-free regulatory approval.

Understanding that your company is responsible for delivering the quality product requires maintaining compliance and quality control. You can lose whatever profit you recorded in the event of litigation from clients and sanctions from regulators. 

For this reason, you need modern Business Applications for the life sciences industry such as PLM Cloud for Life Sciences to succeed. Doing this will give you complete assurance of consistent quality product delivery, quality management process, timely market impact, and avoidance of legal and regulatory disputes. 

Every life sciences enterprise faces new regulatory challenges anytime companies enter new markets. Therefore, you can't have a system of managing quality without real-time information. No matter the qualification and experience of your staff, they must be as good as the information they get.

To achieve value for time, price, and quality, your enterprise needs a system like PLM Cloud to make it happen on demand. PLM Cloud for Life Sciences is an essential quality management element critical for success. 

PLM Cloud for Life Sciences


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Product lifecycle management (PLM) offers the life sciences industry a complete solution to quality management compliance. It is a modern life science compliance solution specializing in sourcing, engineering, and industry compliance processes.

In simple terms, PLM Cloud handles data management and designing processes, engineering, manufacturing, sales, and services of life science devices. Its adoption gives you the control in managing different types of time-sensitive data, like item data, part and product data, product documents and requirements, and engineering change orders.

While PLM Cloud helps product development engineers design and manufacture quality products, it also enables life sciences enterprises to produce quality products and achieve business goals. In a nutshell, PLM Cloud helps lessen losses and increase profitability.
Essentially, PLM Cloud benefits life sciences companies through:

  • Timely access to the market, thereby decreasing costs and increasing returns.
  • Increased staff collaboration and maintaining product quality.

Main features of PLM Cloud

  • Centralized Data Repository and Collaboration Tools.
  • Content Authoring and computer-aided design, engineering and manufacturing.
Although PLM cloud applications meet the needs of these modern applications, it is best to consider a solution that integrates the key processes.

Oracle Quality Management System 

The duty of any life sciences enterprise is to satisfy the market and regulators. Thus, meeting and improving product quality is a challenge for many organizations. In contrast, the success factor for many life sciences enterprises lies in achieving consistent product quality and the best solution for this is the Oracle Cloud Quality Management System.

Oracle provides a modern system of managing quality for the life sciences industry when it comes to handling quality compliance. It helps define, identify, analyze and track quality activities for overall effectiveness, safety, and profitability.

Also, Oracle PLM cloud supports regulatory compliance processes and essential product quality requirements. It is a modern product lifecycle management solution for efficient product development processes. This application helps manage items, parts, and products efficiently while ensuring quality global supply chain workflows. There are several use cases for Oracle Cloud PLM that life sciences companies can explore.

Without the right tool, meeting regulatory requirements for the life sciences industry will be tough. The importance of a quality regulatory compliance system is to prevent trouble without affecting profit margins. Oracle Cloud Quality Management offers the following solutions:

  • Connected quality management in the cloud
  • Effective identification of non-conformances through inspections
  • Manage quality issues and corrective actions
  • Graphic tracking and tracing of materials through their lifecycle
  • Real-time accessibility through cloud applications

Oracle provides corrective and preventive actions throughout the product lifecycle management through these practicable system modules of managing quality. Their implementation gives  life sciences enterprises the confidence to meet local and international compliance and market needs. Once these critical compliance challenges are solved, it creates the environment for success and a high ROI.

Employee Training Management

GoSaaS Datasheet ETS


GoSaaS Employee Training System (ETS) ensures that the employee training process is smooth and enables the organization to keep track and monitor the training; one platform for all solutions. Our out of the box system aids the employees in becoming compliant with their organizations training.


Implementing PLM Cloud for Life Sciences requires knowledgeable employees. Most life sciences enterprises face a challenge when meeting a number of compliances. If this is not resolved, handling processes, work instructions, learning materials and regulatory training become overwhelming. So, there is a need for skilling and reskilling of staff to ensure a quality management process.

Regulatory Compliance

With regulatory and market requirements that are rapidly changing, the life sciences industry is constantly under pressure to satisfy various challenges like globalization, heightened transparency expectations in addition to increasing emphasis on innovative technology.

More importantly, these compliances are ever-changing. Thus, companies are constantly working to understand these compliances and meet them inarguably. Meeting regulatory compliances with an old and inefficient system makes it more difficult, if not impossible. Hence, several companies have difficulty meeting these industry regulations.

While drowning under immense pressure from local regulations, the ISO international compliance is another challenge which every life sciences enterprise must meet to sell in the international market, and the ability of life sciences enterprises to meet up with these ISO compliances and certifications allows them to have worldwide market access, lower costs of doing business, and build customer confidence for safety and product reliability.

Meeting key trends in life sciences product compliance is an essential success strategy. The challenge, however, is the transition from an obsolete system to a modern system. Overcoming this will increase their ROI and give them market leadership.

Do you need an implementation of a quality compliance solution? Get in touch with GoSaaS today.

Topics Oracle PLM Cloud, Oracle Quality Management, Life Sciences