The business case for EQMS in GxP-regulated environments

Whether you need to comply with GDP, GDocP, GCP, GMP, GLP, or a combination of several GxP regulations, your focus is always on patient safety.

However, patient safety isn’t possible without product quality, data integrity, controlled records, a risk-based approach, trained staff, and integrated systems¹.

So, how do you time- and cost-effectively collect, manage and distribute the controlled information you need to demonstrate compliance for your regulatory submission and to have complete confidence in the safety of your device, drug or trial?

medical devices qualsys

Electronic quality management software enables your business to automate the time consuming quality control and compliance activities such as:

Document, electronic signature and record control
Training record and competency management
Issue, CAPA, NCR, change and audit management
Risk assessments

In this post we've shared the business case for investing in an EQMS.

Download the business case for an EQMS in GxP-regulated PDF now:

Business case for EQMS in life science

Reason for not getting an EQMS	A very good reason for investing in EQMS
“We are getting by ok using manual, paper-based processes.”	When using EQMS, organisations see on average 50% time savings compared with manual processes¹. In GxP-regulated organisations, time is more important than ever as there is a race to innovate. EQMS enables you to get your product to market faster.
“We haven’t had a recall yet!”	Drug and device recalls are on the rise. In 2019, the FDA recalled 30% more drugs compared with 2018². Contamination, mislabelling, adverse reaction, defective product and incorrect potency were the most common issues. EQMS and Qualsys services can help you plan and prevent product recalls by improving your product quality and data integrity processes. Our holistic approach to transforming your company culture makes your business more resilient.
“Data integrity is the responsibility of the quality team.”	Data integrity requires a rigorous and holistic structure. Best practice must be embedded throughout the organisation³. EQMS makes it easier for your quality team to make data integrity part of the daily routine – by capturing the fields and information required for employees across your organisation.
“The cost of validating the system is 2x more expensive than the software.”	Qualsys provides an end-to-end GAMP 5 CSV service which ensures you have the documentation, templates, training and support to make validation an efficient, easy and enjoyable process. We’ve provided completely validated solutions in under 5 working days. You will have a dedicated CSV team who ensure your ongoing validation needs are appropriately managed. We also provide support when you are audited. Read more about our validation services here
“We can’t afford a new quality management system right now.”	It’s often a race to get products to market. Everyone is battling for limited resources to achieve the goal by the deadline. However, the cost of an EQMS dwarfs the cost of a delay in your submission due to missing records, re-actively fixing an audit NCR, or product quality issues.

It’s an interesting period at the moment because regulators and industry are realising that there has been historically too much of a focus on compliance and manual quality control activities. Although this is very important and essential – the real focus should be on quality improvement.

When there aren’t the tools and systems in place, this means there isn't enough resources or energy to put time into quality improvement – where 80% of effort should be. Currently, this is around where 20% of time is spent. This means we’re not focusing on the bigger picture – which is patient safety. We’re focused on line-by-line compliance. Our focus should be on critical thinking and risk-based agile approaches to streamline assurance activity and evidence capture.

Sion Wyn - Conformity

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What you should do now:

Qualsys provide the UK’s highest rated quality management software⁴, combined with best practice implementation services and expert support.

We are 100% committed to helping you automate compliance, get your products approved to market, and have complete confidence in your processes and procedures.

To learn more about EQMS by Qualsys and get support building your business case, click the below links: