Electronic Quality Management Systems (eQMS)

Use an eQMS to automate document control.

The conventional approach to quality management involves generating an ever-growing collection of standalone documents that can enable point-in-time analysis of historical data. There are three things wrong with that sentence and the approach: standalone, point-in-time, and historical. In contrast, electronic systems offer dynamic and connected document management in real time.  

Quality personnel can use an electronic quality management system to manage the latest versions of documents from various entry points. They can share documents with partners or inspectors without having to track them down. Documents are always current, complete, and accurate due to process and data controls. When combined with a robust reporting application, you can quickly analyze large amounts of real-time data and use it to gain predictive insights.

Use an eQMS to automate training management.

Staying up to date on training is an ongoing compliance concern that often shows up in warning letters and observations from regulatory bodies. In a paper-based system, it is easy to overlook missed training and not have a clear picture of who needs to be trained on what and when. 

Using an electronic quality management system it becomes possible to oversee an efficient employee training program – one that will never be at risk because of inadequate employee training. eQMS software can automate all training tasks including routing, tracking, follow-up, and escalation. Intelligent systems can even predict overdue training and/or recommend needed updates. 

Use an eQMS to automate CAPA, deviations, and nonconformance management.

Quality is hard enough when your QMS is running smoothly. When you add managing quality events to the mix, it becomes much more challenging, especially if you’re in the business of developing complex products. Effective quality event management (QEM) must include taking preventive steps aimed at detecting potential problems or nonconformances and eliminating them. How do you do that? 

The key to effective QEM is to use an eQMS to automate the management of quality events. With data-driven analytical tools, you can more easily gauge the level and frequency of problems and identify them in real time. You can automatically execute resolution protocols accordingly and preserve your corrective action/preventive action (CAPA) system for your most critical problems.

Use an eQMS to automate audit management.

Fulfilling regulatory requirements requires adherence to good manufacturing practice (GMP) outlined in federal codes and international standards. Quality leaders go beyond GMP to innovate and model best practices.  

Striving to achieve high quality goals and remain in a continuous state of compliance is demanding to say the least. The key is to be able to demonstrate compliance at all times, even when documents and processes are in flux. Time never stops for quality.  

An electronic quality management system equipped with audit management tools is worth its weight in gold because it can automatically keep track of the who, what, when, and where – known as a timestamp – related to each action. It can also record and store 21 CFR Part 11-compliant e-signatures.

Use an eQMS to automate risk management.

Risk management is more than a buzzword in quality management. It’s the sweet spot where innovation can occur without risking compliance or product failure. Managing risk well is a tenacious reality and a necessity to maintain operational stability, right alongside ongoing compliance. 

Avoiding risk isn’t the answer, nor is it even possible. Throwing caution to the wind is also not the answer. It’s more about finding the balance between risk and reward without ever straying into hazardous territory.  

In order to find the balance and the sweet spot, leverage electronic quality management software that comes equipped with a risk matrix and can automatically notifies users when the balance is lost. An eQMS can connect you with other related functions such as documents, training, and QEM so you can efficiently keep risk in check without introducing more.