Implementing a Quality Management System (eQMS) in the life science industry is a critical decision that requires careful consideration, holding substantial weight as the chosen eQMS will likely influence business operations for the next 3-5 years. This guide aims to shed light on three key factors crucial for a successful eQMS project.
1. Selecting the right eQMS software and vendor:
It’s essential to strike a balance between meeting technical and regulatory requirements. However, finding a solution that perfectly aligns with all requirements is challenging. While fully customizable options exist, they often come with significant costs and project risks, such as delays, changes in requirements, or dealing with unforeseen challenges. Therefore, we encourage you to explore off-the-shelf software that can be tailored to fulfill most of your needs using configuration or no-code tools, rather than opting for fully customized solutions or attempting to develop one yourself. In addition to functionalities, user experience is equally important, as a poorly designed system can face resistance, especially in companies new to digital transformation or those with conservative cultures. Lastly, ensure you consider a vendor that understands the complexity of the regulated life science industries.
2.Partnering with a trusted partner:
Transitioning from selecting the software to the actual implementation, the importance of a trusted implementation partner cannot be overstated. Regardless of the quality of the chosen software, success hinges on having a competent and experienced implementation partner. A reliable partner should understand Good Manufacturing Practices (GMP) and it’s relevance to how IT projects are managed. Communication also plays a crucial role throughout the project. Having implementation partners who can communicate in the local language is a significant advantage, as it could prevent loss in translation while describing your requirements. Caution is advised against potential implementation partners prone to false promises, as it can lead to mistrust, hindering the project’s success. For example, if a partner commits to delivering the project on a similar scale to others but with only fraction of the project time, take a step back to make further assessments and see if the commitment is legitimate.
3.Sustaining eQMS operations:
The last, but not least part of this article is about sustainability, which becomes a focal point once the eQMS is operational. Beyond the go-live stage, maintaining the infrastructure supporting the eQMS is vital. Robust backup and disaster recovery plans are essential, and cloud infrastructure is gaining more popularity here for its efficiency, cost-effectiveness, and extremely high security and procedural controls achieved through the providers economy of scale. Selecting software that allows further configuration without constant reliance on vendors or implementation partners is key to controlling long term costs. Additionally, given that the software is managing GxP, corporate, and quality data, Computer System Validation (CSV) is mandatory, so choosing an eQMS solution that offers tools to streamline the validation process is a huge plus.
In summary, the journey of implementing an eQMS is not just about finding a tool; it’s about establishing a strategic partnership for long-term success. While the process may take more time than expected, the investment is undoubtedly worthwhile.
If you are interested, you can download a comprehensive buyer’s guide from MasterControl, the industry-leading eQMS for life sciences, from here.
Factorytalk, a trusted partner of MasterControl with two decades of compliance x business expertise, is ready to support you on your eQMS journey.
Feel free to reach out, and let’s ensure the success of your eQMS project.
