Life Sciences: Five Considerations for an Electronic Quality Management System

Have you ever wondered how some life sciences organizations manage their quality process so well, while others just feel stuck in aligning their processes, right? On top of it, the quality issues in the pipeline are just increasing. 

You are not the only one facing this issue!

We all want to drive a culture of quality, compliance, and excellence that reflects every product, process, and service. But, most importantly, the customers must have enough confidence in the brand for the product quality and safety to keep coming back and recommending it to others. 

The first step in achieving operational excellence in life sciences is implementing a comprehensive quality management system. 

Why does Lifesciences need a Quality Management System?

A quality management system is essential in defining what quality means to a life science company and aligning it with regulatory requirements and customer demands. 

An organization’s Quality Management System (QMS) helps it achieve compliance and consistently deliver high-quality products. The purpose and goals of an organization should be translated into policies and resources, which encourages all members of the organization to adopt standard operating procedures (SOPs).  

Setting up a quality management system serves three critical purposes: 

• ensuring consistency,  
• demonstrating transparency to regulators,  
• and defining what quality means within an organization. 

In recent years, quality systems have evolved slightly, but management frameworks have remained essential for ensuring consistent quality. Organizations in the life sciences and other industries use quality management systems to improve processes, optimize continuous improvement efforts, and adopt data for evidence-based decisions. For example, a highly regulated pharmaceutical sector often seeks certification with internationally recognized standards such as ISO 9001 to improve quality through documentation, transparency, and systematic approaches. Quality management software helps modern firms to meet their quality management requirements.

The QMS can help to improve compliance, profitability, and quality culture. However, certain core elements must be present for a life sciences company to reap the benefits of its quality management system truly. The core elements of quality management assist in determining quality objectives, ensuring compliance with all product development steps, and monitoring the opportunities for continuous improvement. 

Related Topic - What do you need to do to ensure nutraceutical industry compliance

Life Sciences: Five Considerations for Choosing the Right EQMS

Consider what your organization needs from a Quality Management System (EQMS) to determine which vendor and system are suitable for your organization. During the selection process, consider the following: 

1. Determine what your organization needs from an EQMS 

   It would be best to decide what quality processes you want to manage within the system. For example, would you manage only controlled documents or other critical functions like audits, training, CAPAs, and customer complaints? Starting out, you may only use auditing solutions, but as your business grows, quality management systems mustbe able to provide the support you need. You can make the best decision regarding the type of system you need if you consider all needs for the quality solution. 

2. Engage your employees in quality activities 

   Regardless of how an EQMS is implemented, it is vital to consider the requirements of all departments who will interact with the quality system, as well as your Quality Assurance Group. It is a good idea to create a cross-functional team for evaluating needs to gather all input and requirements from the various business units. You can either manage this in-house or have a third party handle it, but having the right people participate in the discussion early on is crucial. 

3. Make your choice between ready-to-use preconfigured or configurable systems that grow with your business 

   Suppose you want to determine which type of quality management software is the best fit for your organization. In that case, you need to consider two factors: whether your existing processes fit into a preconfigured, out-of-the-box system or a customized system tailored to your organization’s specifications is more suitable. 

   Your budget may be affected after discussing and analyzing the requirements you have. But, sometimes, your budget may also determine what kind of system you choose. 

4. Do not underestimate the budget factor for choosing your EQMS  

   Selecting the right EQMS vendor for your budget can be challenging since many EQMS vendors exist. In cases where budget limitations govern the selection of your EQMS, an off-the-shelf hosted solution might be more practical than implementing an on premise customized QMS. Understanding all company requirements and associated costs is crucial when implementing an off-the-shelf, cloud-based, or on-premises customized solution. The best system is the one that meets your current and future needs. 

5. Make sure you consider the validation process and its costs too 

   Most quality management software vendors provide you with a validation documentation package and template IT SOPs that You will need to use and implement the EQMS. However, vendors may charge additional fees for validation, or you may need to hire a third party. Perhaps this is a hidden cost that you were not aware of earlier. Make sure you know the requirements for having your EQMS system validated and what changes will need to be made. 

Some Other Considerations You Can Have 

In addition to the considerations listed above, you may list the other factors that are important for your organization. For example – you may need an EQMS that facilitates real–time collaboration and communication among teams working worldwide. Or you may need a system that can seamlessly integrate with your existing enterprise quality systems. This is especially important for regulated industries that require complete control on processes and data. 

Bonus Tip: Ask your vendor or quality solution provider if they have ever worked with regulated industries like yours. You will gain a better understanding of their credibility and accountability. You can consider looking at their customer testimonials too. 

After all the evaluation, if they are a great fit for your EQMS requirements, get a free product demo scheduled to experience the functionalities and capabilities in real time. It helps you make an informed purchase decision. 

We do understand the struggle of choosing the right Enterprise Quality Management Software for the Lifesciences industry, especially when the regulatory standards are getting stringent every day. We would like to make things a little easier for you with a quick recommendation. 

Now that you have already decided to upgrade to a next-generation Quality Management Software, you must give Qualityze EQMS Suite a thoughtful consideration. It is a cloud-based, intuitive, and configurable solution to pace up with your growing business needs today and tomorrow. It is built on the most powerful and secure cloud platform, i.e., Salesforce.com. It comes with impressive functionalities and features. You can integrate it with your existing quality systems too.  

In addition to feature-packed quality solutions, Qualityze promises hassle-free data migration and validation services so you can have everything under one platform. Isn’t it an investment-worthy solution? 

Related Article: The Main Challenges in Data Migration and How to Effectively Overcome Them

The free demo of the product is available here. 

Request a free demo today and experience the difference Qualityze EQMS brings in the way you manage quality, safety, and compliance. 

If you are interested to know more about Qualityze EQMS Suite or any of our smarter quality solutions, feel free to contact our customer success team at info@qualityze.com, or you can give us a call on 1-877-207-8616, and our team will get back to you as soon as possible.