Digital Transformation in Quality Management

Digital transformation allows for closed-loop digital quality management.

The current emphasis on distributed quality methods, such as quality by design (QbD) make it imperative to adopt digital quality management solutions to help you design quality into the entire product life cycle. You can avoid pitfalls upstream rather than trying and fix them later when it’s more difficult and costly. 

Having real-time visibility into your processes is possible with an eQMS. You can quickly automate quality processes and manage quality events even beyond production to achieve a culture of quality – one that can focus on the continuous improvement of your products without getting stuck in the details of quality management.

Digital transformation supports your regulatory compliance strategy.

Regulatory bodies are dedicated to product efficacy and consumer safety. Inspectors are pleased, not to mention relieved, when you can quickly provide the require documentation to prove your compliance efforts and your documentation is complete and accurate. Manual systems cannot offer this degree of audit-readiness. With the increasing number of remote inspections taking place, this has never been truer.

Planning and following through with digital transformation in quality management brings its own rewards. The sooner you implement an eQMS, the faster you can pass through successful inspections and audits. Subsequently, you’ll garner more trust from regulatory bodies which may reduce oversight as well as increase your brand equity. 

Digital transformation enables timely collaboration among stakeholders.

A large part of quality management involves change control. Quality organizations strive to achieve a state of continuous improvement – all while remaining in compliance. This can mean an endless cycle of document revisions, reviews, and approvals. Your ability to comply with evolving regulations and customer demands depends on how responsive your QMS is.  

Hands down, one of the biggest advantages of an eQMS is that your documents are stored electronically in a single repository. This makes it possible for all stakeholders to access the latest documents in real time to complete timely reviews. Compliant e-signatures and cloud technology makes it even faster.

Digital transformation automates training management.

Training deficiencies contribute not only to quality missteps and delayed progress. They can also lead to compliance failures, dangerous products – and ultimately, shutdown.  

Training failures continue to be a primary reason for compliance failures. This implies that managing training is not an easy task, but rather one that can quickly get out of hand. This is especially apparent if you rely on paper forms and paper-based processes to fulfill training requirements.

When you can access training and testing materials and embed training requirements directly into your quality processes via an eQMS, it becomes nearly impossible to miss them. But if you do, you can easily track that too.

Digital transformation offers robust risk management tools.

Taking a risk-based approach to quality management is one of the key tenets of successful compliance. Industry 4.0 technologies such as digitization, automation, and integration make it possible to efficiently design, streamline, maintain, and modify an eQMS – one that helps manage higher risk without having to interrupt or shutdown continuous improvement efforts.

An eQMS helps quality organizations take human-error out of the equation and standardize their risk matrix. This can effectively solve the following challenges of risk management: inherent subjectivity in risk assessment, inconsistent mitigation, and the complexity of identifying sources and designing mitigation strategies.