The transition from a QMS based on various digital tools and paper-based documentation to a more powerful electronic quality management system (eQMS) offers many benefits and important features to help companies improve their business and organization. Below are some things to consider.
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There is a difference between a QMS and an eQMS
The main difference between a manual and an electronic QMS is that the latter relies on advanced software specifically designed to help companies manage and document the often complex and extensive processes of quality management. Life science companies must comply with strict regulatory requirements and standards that can ultimately be a matter of life and death when it comes to patients, for example. When it comes to work processes, best practices must be applied, which entails extensive documentation. We are all used to working with digital tools and applications daily, but working effectively with an eQMS can bring great benefits to an organization.
Six benefits of an eQMS that improve operations
- Better documentation management – an eQMS ensures that the latest approved versions of documents are available to relevant users. The system manages and tracks documents and manages permissions based on user profiles and responsibilities.
- Better traceability – an eQMS makes it easier to keep track of permissions, changes and electronic signatures while improving traceability with a clear audit trail. It is a security for both the organization and the individual employees to know that everything that is documented is traceable and that the handling of data and documents is done correctly.
- Better case management – life science companies often ask about how to manage corrective and preventive actions (CAPA). An eQMS with good case management provides a valuable overview of what changes have been made and why.
- Better preparedness for inspections – an effective eQMS makes it easier to keep track of all documents and processes, which means better preparedness when the time comes for either an internal audit, or a customer or government inspection.
- Professional risk mitigation and management – some companies conduct risk analyses, record them in an Excel document and then forget about them. Working effectively and actively with risk management is important, especially for companies in the life sciences industry where a lifecycle perspective is required. An eQMS helps to structure and organize the work with risks, which includes the detection, analysis, and quantification of risk as a function of probability and consequence. As a result, it makes it easier to address and regularly monitor risks.
- Better control of skills – another issue that often arises for life science companies is how to ensure that their staff are properly educated and trained in the various procedures and practices that apply to their operations. Insufficient training can degrade a company's products & services, which can be devastating both for those who need the products and the company's reputation. A well-designed eQMS can ensure that staff have the required skills.
An eQMS connects the WHAT with the HOW
Compliance and certification are business-critical factors in the life sciences industry. Companies that utilize the full potential of their eQMS increase their chances of achieving business goals and growing.
ISO standards and regulatory requirements describe WHAT an organization must be good at and work with. This is in many cases based on regulatory requirements, best practices and experience and are there to facilitate business. But WHAT is only one part of the equation. The other part is HOW. How should the requirements be implemented and integrated in each organization? The answer is in an eQMS, where the collective knowledge is stored. It links the WHAT with the HOW, which includes compliance & regulatory requirements, operational & organizational competence, and business development. This makes an eQMS a powerful tool to help life science companies accelerate their business.
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