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Prioritize a QMS Process Automation or Risk Failure

Set small, achievable milestones and allocate reasonable time for analysis

Published: Tuesday, May 23, 2017 - 12:01

A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one giant undertaking. However, real-world experience has proven that this approach is just not feasible for long-term quality management success.

What to consider

When prioritizing your quality and compliance processes, weigh the importance and interconnections each will have. The genesis of a leading-edge quality management and compliance ecosystem should start with one process determined by a key driving factor. Consider the following types of drivers when organizing your QMS:

1. Critical noncompliant quality processes
In the most serious cases, automate the most critical process identified as noncompliant. Are your processes failing to meet minimum requirements? Did your team just burn through 600 staff hours preparing for an audit? Even worse, did you receive an FDA warning letter?

2. Ineffective quality processes
Logically, if a process is ineffective, manual, redundant, or exists on a labor-intensive legacy QMS, automate it. Look for processes that are essential to move faster and more efficiently. For example, many organizations start by centralizing the complaint management process. As a result, they see extensive reduction in labor hours, faster time to resolution, and have a single point of reference for all issue management.

3. Good quality processes that should be better
Organizations not under regulatory compliance pressure will benefit by starting with a process of lesser complexity across the quality value chain. A process may be working now but could be accelerated within days of automation. In this case, you achieve a large impact for the least amount of effort.

4. Universal quality processes
A universal process like corrective and preventive actions (CAPA) is the FDA’s most expected platform for maintaining GMP compliance and meeting 21 CFR Part 11 and ISO standards. An effective CAPA plan has proven to lead to other QMS and process improvements.

Avoid the waterfall for QMS process automation

In the traditional developer “waterfall” model, each implementation phase must be completed sequentially before the next phase can begin. In this case, the disadvantage of waterfall development is that it doesn’t allow for much reflection or collaboration. If the design requirements set forth at the outset are faulty in any manner, the project is at risk of failure. In the testing stage, it is very difficult to change something that was missed during the design stage.

For QMS process automation, set small, achievable milestones and allocate reasonable time for periodic analysis.

Select a flexible QMS platform
Whether you select a traditional on-premise or on-demand cloud solution (SaaS), a quality and compliance management system must be flexible. Your eQMS should adapt with your process automation needs as your business evolves. In addition, a system should be configurable, enabling the automation software to rapidly adapt to your processes without large investments for customization. Furthermore, a flexible QMS platform allows the deployment and modification of processes as needed, but has the power to integrate all workflows, data. and documentation into a single system.


Put detailed consideration into the deployment of your QMS process automation strategy. Be clear about which priority is the most critical and set reasonable milestones and expectations. Work in partnership with your QMS vendor to make the project as seamless as possible. The success of your first process launch will set the tone for future system expansion and new initiatives.


About The Author

AssurX’s picture


AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.