Using office applications (intranet, team sites, Excel, file shares, SharePoint, Cloud storage) combined with traditional paper documents as their quality management system (QMS), life science companies quickly realize the shortcomings of maintaining it. It can be an organizational headache that gives your company and colleagues little room to focus on anything else or innovate. But there are other ways of working!
Transitioning from office applications and a paper-based QMS to a more powerful electronic quality management system (eQMS) offers many benefits and key capabilities to help life science companies improve their operations and organization. Here are some things to think about.
Understanding what is an eQMS
The main difference between a manually based QMS and an electronic QMS is that eQMS is based on advanced software designed explicitly as a valuable tool to help companies manage and document the often complex and comprehensive processes of quality management. Particularly in the life science sector, companies must adhere to strict regulatory requirements and standards which greatly impact patients and can be a matter of life or death. Best practices in work processes need to be in place, resulting in a large amount of documentation. We are all used to working daily with digital tools and applications – this is nothing new. But working effectively with an eQMS can have transformative benefits for your organization.
Five eQMS benefits you can leverage to improve your business
- Better documentation management: Having control over permission to access documents, changes to documents, electronic signing, or audit trails are more manageable with an eQMS. This is valuable for both the organization and individual staff members, knowing they can fully trace documents and feel secure that they are accessing and managing the data and documents correctly.
- Support for corrective action: Life science companies frequently ask about corrective and preventative action (CAPA) management. An essential ability of an eQMS is to help organizations implement their corrective actions, processes, and procedures, resulting in effective best practices for corrective actions. The documentation also provides valuable insights about what changes have been made and how.
- Optimize auditing capabilities: An effective eQMS will also help you with all auditing documents and processes. Auditing has a preventative focus and is more proactive in preparing future processes. In comparison, CAPA is more reactive, reacting to current processes that need to be fixed.
- Professional risk mitigation and management: Some companies detect risks, put them in Excel, and forget about them. But as a life science company, you want to be excellent at working with risks from a life cycle perspective. An eQMS can structure and organize how companies work with risks – including detection, analysis and defining risk scores regarding probability and consequences. As a result, it is easier to plan actions and follow up on risks regularly.
- Ensuring organizational skill sets: Another question that often comes up among life science companies is how they can make sure their staff has the right competencies for different tasks within the organization. This is an important aspect - not having trained and competent personnel will impact the quality of your products and services. Poor quality can have serious and devasting consequences for patients. The eQMS will help ensure that you have trained personnel, monitor, and manage the right skill sets to match different tasks.
Connecting the WHAT to HOW with eQMS
In the life science industry, compliance and certification are business critical. Working with the eQMS effectively and taking full advantage of its capabilities can also help you reach your business objectives and grow. ISO standards and regulatory requirements describe WHAT an organization needs to be good at and work with. This is for a good reason and is based on best practices and experience in many cases. The WHAT is just one part of the equation.
The other part is HOW. “HOW should I implement and integrate these requirements within our organization?” Your company’s know-how is the answer and your competitive edge. The know-how sits within the eQMS. It connects the WHAT with the HOW, including compliance and regulatory standards, operational and organizational excellence and business transformation. eQMS is a powerful tool to help life science companies accelerate their business.