How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

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Quality management system, a performance driver

The quality management system represents a challenge for companies. When it is digitalized, it becomes an undeniable performance driver.

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Quality is essential in all fields, and ensuring that quality standards are respected is a priority for everyone at all levels of the product or service life cycle. Therefore, the digitization of quality management systems (QMS) is nowadays inevitable, especially in regulated sectors.

What is Quality Management System Software (QMS)?

Quality management System software is a tool that enables an organization to effectively manage its quality management activities and comply with applicable quality regulations and standards.

It allows a company to plan, implement, monitor, and control its quality management activities. In addition, quality management software can automate and manage various quality management system tasks, such as data collection, analysis, non-conformance management, and stakeholder communication.

QMS software can also help ensure that the company complies with applicable regulations and quality standards and can provide reports and analysis to track progress and identify areas for improvement.

Why implement a digital quality management system?

There are several reasons why (highly regulated) industries may want to implement a digitalized Quality Management System:

  • Product and service quality improvement: a digitalized quality management system can help companies improve the quality of their products and services by identifying and correcting quality issues more quickly and efficiently.
  • Regulatory compliance: In highly regulated industries, it is critical to comply with applicable regulations. A digital quality management system can help companies comply with regulatory requirements by keeping track of all company activities and ensuring that products and services meet required standards.
  • Improved operational efficiency: a digital quality management system can help companies improve operational efficiency by automating specific tasks and enabling better collaboration and communication.
  • Improved corporate reputation: by improving the quality of its products and services and complying with regulations, a company can improve its reputation with its customers and stakeholders.

    A digitalized quality management system can help companies improve the quality of their products and services, comply with regulations, improve operational efficiency and enhance their reputation.

What are the potential barriers to implementing a quality management system?

Implementing a quality management system is a process with limitations that can be overcome with the right solution.

Pain pointsSolutions
Cost
Implementing and maintaining a quality management system can be expensive, especially for small businesses.One solution does not fit all! Quality management software is designed according to the size of the company and its needs. Therefore, avoid "generic" solutions.
Time
Implementing and maintaining a quality management system can be time-consuming, especially if the company has to adapt to new regulations or quality standards.In all cases, the company must adapt to new regulations. Quality management software integrates the updates when necessary. Software that is already compliant facilitates the evolution in terms of time and resources (gain).
Complexity
A quality management system can be complex, especially if the company has many stakeholders and must follow many different regulations and quality standards.Implementing a quality management system must be collegial with all stakeholders to decomplex it. Thus, all key users have visibility in the implementation/modeling of the management platform.
Lack of flexibility
A quality management system can be rigid and inflexible, making it difficult to adapt to changes in the business environment.The choice of the quality management platform must be made with a vision of the company's evolution. QMS applications evolve with the company and its progressing needs.
Lack of employee engagement
If employees are not committed to the quality management system, it can be challenging to maintain its effectiveness.When selecting and implementing the QMS, key users must be an integral part of the process so that all understand the system’s benefits and participate in its improvement.
Weakness of the technology used
If the technology used to implement the quality management system is outdated or unreliable, it can affect the quality of the data collected and the company's ability to make informed decisions.When choosing the technology used for quality management, the platform’s evolution must be a criterion of choice so that the system grows with the company.

Towards a digitalized Quality Management Solution

One of the main reasons to digitize the quality management system is to comply with the regulations in place, as paper forms or Excel spreadsheets are becoming security and data integrity problems. There are several advantages to digitizing your quality management system (QMS) for better compliance with regulations:

 

  • Improved traceability: by using QMS software or applications, it is possible to keep track of all company activities and generate reports that can be used to demonstrate regulatory compliance.
  • Accurate and reliable data: Using quality management software, data can be collected and stored accurately and reliably, which can help demonstrate regulatory compliance.
  • Easy to update: Quality management software makes it easy to update processes and procedures when regulations or quality standards are updated.
  • Improved operational efficiency: By using quality management software, tasks can be automated and time saved, improving operational efficiency.
  • Simplified audit management: Internal and external audit management is simplified, saving time in reviewing data and documents. Centralization of audit activities and follow-up of corrective and preventive actions.

Digitizing its QMS can help a company improve its activities’ traceability, ensure data accuracy and reliability, easily update its processes and procedures in case of regulatory changes, and improve its operational efficiency, especially during internal or external audits.

Implementing a new quality management system or improvement through digitalization is a strategic issue for all companies that depends on several factors: the company’s size, the complexity of the processes in place in the different departments, and the company’s long-term vision.

In all cases, data integrity, compliance, and resource savings (time, cost, and human) are competitive advantages that companies must have today. Quality management system digitalization solutions are available, have a look at QMS-4-SME.