Is your company ready to step into the future of quality management? Electronic Quality Management Systems (eQMS) offer a revolutionary way to structure, integrate and automate quality processes, such as document management, training, deviation and change management. But how do you best navigate the transition to an eQMS and what are the steps involved? In this article, we explore the path to a smooth implementation and the challenges that may arise along the way.
Future-proofing workflows: Transition to eQMS
As teleworking becomes more common, the need for agile and efficient quality management systems has become increasingly apparent. Traditional paper-based systems face challenges, especially so during the pandemic years, when the need for remote signing and access to electronic documents suddenly became critical. But why would you choose to move to an eQMS?
Hybrid systems, which combine both paper and electronic documents, may seem satisfactory at first, but these systems can quickly become complicated and resource-intensive, with a lot of manual steps and the risk of errors. An eQMS offers a solution to these challenges and provides additional benefits. By streamlining and automating work processes, the risk of errors can be minimized and efficiency improved. For example, the integration of document and training processes can facilitate users and ensure that the right people are informed at the right time.
In addition to minimizing risks and errors, the eQMS enables easy tracking of training, review dates and case management. Reminders can be automatically sent to users when a task is approaching its deadline, helping to ensure that work processes are followed correctly. Overall, the quality management system becomes easier to use and maintain, while reducing the risk of errors and deviations.
Key considerations when choosing an eQMS - expert tips
Choosing the right eQMS
Navigating the different options of electronic quality management systems can be a challenge. It is therefore particularly important that those making the choice understand that different systems are suitable for different businesses. Factors such as company size, number of users, internal IT infrastructure and quality management system requirements can differ significantly, making it difficult to find a universal solution.
Considerations when choosing an eQMS
An important start when choosing an eQMS is to assess the flexibility of the system. A flexible system offers the possibility to customize and configure processes to suit the specific needs and wishes of the company. While this can extend the implementation time, it can make the transition to the new system smoother by adapting to existing work processes. On the other hand, an eQMS with pre-built processes and low flexibility is usually faster to implement, but requires major changes to existing work processes.
"Afurther tip is that it is also important, in addition to the system, to consider the supplier and their quality management system. Questions to consider include the extent to which the supplier can help with configuration and validation, whether the system is cloud-based, how often it is updated and how this might affect the company's operations." - Mattias Anderson, Senior Consultant Quality & Compliance.
Step by step: Implementation and validation of the eQMS
When it comes to implementing and validating an eQMS for regulated activities, it is important to follow a structured process. Here is an overview of how it works:
- Validation of the system: Many suppliers offer eQMS that are already validated, but this usually only covers the basic functionality of the system. The customer needs to complement this with validation of the specific configuration and ensure that all user requirements are met.
- Development of procedures: Procedures for how the organization will use and administer the new system need to be developed and documented. This also includes adapting existing work processes and procedures to the new system.
- Migration of data: A challenge is to move existing documents to the new system in a controlled manner. This requires careful planning and execution to ensure that no data is lost.
To ensure a successful transition to an electronic quality management system, you may need support throughout the implementation phase, such as experienced project managers, validation managers and QA specialists. This way, the project is efficiently managed and the internal workload is minimized while the eQMS implementation is carried out in the best possible way.
Undertaking an eQMS implementation offers several benefits to your business, including:
- Efficiency: By streamlining and automating quality processes, companies can increase their efficiency and productivity.
- Quality assurance: An eQMS enables more accurate management of documents, reducing the risk of errors and discrepancies and ensuring higher quality.
- Increased compliance: The system can help the company meet regulatory requirements and standards, reducing the risk of fines and lost revenue due to non-compliance.
- Traceability: Having a centralized platform for managing documents and processes makes it easier to track and review history and changes.
- Cost savings: By reducing manual processes and errors, companies can save time and money in the long run.
In summary, an eQMS implementation allows your company to increase efficiency, quality assure your processes, meet regulatory requirements, improve traceability and reduce costs. Take the step today towards a more digitalized business and see the positive effects tomorrow. And beyond.
