Life science companies are subject to continuous and rigorous scrutiny by various regulatory authorities and organizations, such as the Swedish Medical Products Agency (MPA), the US Food and Drug Administration (FDA) and notified bodies. The regulations are designed to protect humans and animals by ensuring that the products prescribed are effective and safe to use. They cover medical and veterinary products as well as biological and medical devices. In addition, there are internationally agreed and industry-specific standards that define the requirements of a QMS.
Time-consuming management and administration
A lot of administration is required to manage a fragmented QMS that is spread across different applications. Monitoring, controlling, and managing documents in different formats and on different servers takes significantly more hours than if the formats are fewer and everything is gathered in one system. In addition, the user experience is poorer, as is accessibility and searchability; the QMS becomes focused on file sharing rather than quality and compliance. In addition, using both digital and physical documents requires extra manual effort, which increases the risk of human error leading to misplaced or lost documents.
For life sciences companies, it is important that documents are managed in a secure environment and that all aspects of documentation management are done reliably – from creating, updating, and approving documents to distributing and archiving them. A combination of different digital tools for managing and archiving documents increases the risk of employees accessing or acting on outdated and inaccurate information.
Difficult to improve processes and workflows
One requirement of a QMS is that companies should be able to define and demonstrate their quality processes to ensure that they always follow best practices.
It is not possible to get an overview of work processes in a fragmented QMS consisting of different digital tools and workspaces scattered in multiple locations. This makes it difficult to work together effectively and introduce new methods or procedures.
Not knowing what needs to be improved, or how to implement organizational and operational efficiencies, affects an organization's ability to meet standards and requirements. Without a way of doing things, there is a high risk that individual employees will develop their own ways of working, leading to even more disconnected organizational processes, with inefficiencies and critical mistakes as an imminent risk. With all of a company's administrative resources centered around document management, its quality and customer focus will be limited.
Ineffective processes
A quality management system should support the execution of processes. Compared to a fragmented QMS, a unified and powerful QMS will dramatically increase the efficiency of day-to-day production by supporting the processes of audit compliance and corrective and preventive action (CAPA) management. The increased data collection capabilities, combined with relevant and reliable metrics, provide important insights into work processes, and help prioritize and guide decision-making. In other words, it is difficult for organizations to develop their business without an effective eQMS.
Lost insights lead to lost revenue
While different systems and formats may work for the short-term, day-to-day collaboration needs of a life sciences company, using them as a QMS can have long-term consequences. Insights and lessons learned over many years, throughout a product's lifecycle, risk being lost when staff leave. And when insights and lessons are lost, so are business opportunities.
As a company grows with more employees, larger market shares and/or more markets, fragmented or inadequate quality management systems become increasingly difficult to maintain. They are neither scalable nor cost-effective.
An electronic QMS is a prerequisite for quickly meeting market needs
The Covid pandemic highlighted the importance of being able to quickly deliver approved products to the global market. A life sciences company with the ambition to meet market demand without delay needs to be flexible – all documentation, processes and certificates must be in place. Those using eQMS software designed to manage compliance processes and procedures will have a major competitive advantage. It will be easier to collect relevant and reliable data and thus much easier to make the right decisions.
An eQMS protects your company's know-how
Our eQMS – CANEA ONE – is an IT platform that helps life science companies complement their existing digital work tools with a comprehensive eQMS suite that is easy to customize, simplifies document management and makes work processes more efficient. In addition, there is full traceability of all events in the system and built-in functionality for electronic signatures and staff access to relevant documents.
"Documentation, such as procedures and processes, are the know-how of life science organizations and vital to their success. This knowledge is inside the eQMS and needs to be made easily accessible and manageable for all employees, while being properly controlled and protected. We can help with that."
Daniel Sten, Head of IT at CANEA
