To meet the requirements of various authorities and customers, changes to processes must be documented and the documents must be easily accessible. An electronic quality management system (eQMS) can give quality managers and the entire organization peace of mind knowing that you have a powerful tool to manage and document your processes for quality, compliance, and product development.
eQMS – one of the most important systems
There are many systems and tools that help a company manage its operations, but an eQMS is one of the most important when it comes to ensuring that the company meets regulatory requirements. Regulations are mainly about documenting what is to be produced and how it is done, i.e. the processes. This means ensuring that all employees always use the latest approved version of a procedure or the latest approved safety data sheet for equipment or material. As well as being able to demonstrate that the relevant people are trained and approved for the tasks. A modern eQMS has the functions and capabilities needed for this.
A regulatory or customer inspection often evaluates certain aspects, such as:
- Employees have read and understood the latest valid versions of relevant documents – eQMS features such as electronic signatures allow employees to acknowledge that they have 'read and understood', providing traceability of documents read and training completed.
- The latest approved versions of documents are in the right place in the system and accessible to the relevant users – an eQMS manages and tracks documents and manages permissions based on user profiles and responsibilities.
- The documents for the relevant process sections are easily accessible to the operators.
Easier to focus on improvements with a coherent eQMS
With an eQMS, you can capture important customer complaints with traceability. You can see if someone has responded to a complaint, if it has been forwarded to the right addressee or if it should be handled as a CAPA (Corrective Action and Preventative Action). An eQMS helps to ensure that the right departments are involved in analyzing what went wrong and that the right actions are taken. A well-configured and interconnected eQMS provides full traceability from start to finish and ensures that both quality and safety are maintained.
Validation of quality using an eQMS
Another important aspect of the regulatory requirements is the validation of processes. For example, authorities and customers want to see documented evidence that what should be validated has been validated. This can include the production process, the systems, what tests have been done and what the results were, and what actions have been taken. An eQMS helps handling the validation process and its documentation.
The basis for continuous improvement
The functions and possibilities that an eQMS offers to continuously improve an organization, or product, are something that the entire business can benefit from. For example, the management of documents, risks, training, audits, deviations, CAPA or the support of other quality processes. Moreover, when everyone uses an eQMS, it becomes much easier to get everyone pulling in the right direction. An eQMS prepares the organization for inspections and ensures that regulatory content is both in order and easily accessible. Organizations that are well prepared, in terms of regulatory requirements, can bring new products to market faster and more efficiently, without compromising quality.
Learn more about how CANEA ONE can help you and your organization meet regulatory requirements.
