Embracing an electronic quality management system

Electronic Quality Management System (eQMS)

There is no doubt that an Electronic Quality Management System (eQMS) offers real business value and therefore have gained increasing popularity within the healthcare industry over the last decade for very obvious reasons. Increasingly, we are seeing people using a standard Microsoft solution, SharePoint as their Electronic Quality Management System of choice, as it now ships with a Part 11 compliance “switch”, i.e. an audit trail. As most companies need Office 365 anyway, so SharePoint is free, just needs some configuration, a bit of tweaking, add some workflows and Power BI for continuous PQR and you away, obviously this has some cost.

Speaking of costs, after-sales service is readily available, at competitive prices, just run an ad tomorrow for SharePoint consultant, and you will see what I mean and the best part, your staff arrive being trained in SharePoint, Microsoft now estimates that 80% of Australian professionals arrived experienced in the use of SharePoint! Looking for a SharePoint EQMS, why not speak with QikSolve, experts in replacing paper QMS systems.

A significant advantage is the longevity of the after-sales support, no company provides the same credible 10 year after sales product support, the GFC taught us that some companies are too big to fail, most will agree Microsoft most likely falls into this category.

The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS:

eQMS Diagram

Countless software systems have emerged to replace the conventional paper-based processes, with claims to help organisations improve QMS quality, effectiveness and efficiency. But how does an eQMS achieve this?

1. Connecting the organisation

Often, a paper-based QMS tends to widen the gap for quality system collaboration within departments in an organisation, making quality integration tedious. The infrastructure of an eQMS allows for an online multi-department focus on quality issues and makes it easier to achieve inter-department communication when it comes to solving those issues.

2. Real-time data management

Industry standards and guidelines require time-sensitive QMS processes, including Corrective and Preventative Actions (CAPA), Change Control, Deviations and Complaints, to record data history from initiation to closure, and during post-closure effectiveness reviews. Using an eQMS ensures real-time management of recorded data, and manages timely closures of Quality Improvement and Quality Control processes. In addition to eliminating paper-related concerns such as duplicate or lost documents, and uncontrolled versions, an eQMS is also able to automatically track and trend metrics for management reviews.

3. Increased accessibility

Paper-based QMS documents have the obvious downside of restricted storage locations and limited access, which is often violated with no documented record of changes made or by whom. The introduction of a robust electronic system ensures anyone with a login ID and unique password has appropriate access to view and edit quality records with the safety net of increased visibility, change accountability and document traceability.

4. Inspection Readiness

A one-stop-shop that contains quality records along with documented evidence, all available at the click of a button, can only be beneficial to maintaining the organisation at an inspection-ready state at all times. It ensures that record retention policies are adhered to and makes the retention and retrieval of records more efficient.

5. Time and planet-saving

Lastly, the obvious benefits of an electronic quality management system do not escape the minds of environmentalists. In addition to saving trees and reducing waste, the implementation of an eQMS saves time (and cost) in managing and controlling documents and registers, document approval workflow, training management and competency assessments.

Ready to take your company into the paperless QMS world, why not read what QikSolve has to offer?

Alternatively looking for 10 tips improve your QMS or implementing a QMS?