Unlike companies that operate in non-FDA regulated industries, pharmaceutical and medical device companies may take more time to adopt cloud applications. Cloud computing may challenge what these companies have grown accustomed to. But just like their non-FDA regulated counterparts, these companies are under pressure to lower operating costs without disrupting product quality, safety, efficacy, and supply chain continuity – all with the added responsibility of maintaining regulatory compliance.
Cloud quality management system (QMS) software is a game changer because it will help pharmaceutical and medical device companies lower their total cost of quality while maintaining regulatory compliance in ways that weren’t possible with traditional on-prem applications. Here are four ways cloud QMS is changing the game for FDA regulated companies.
1. By Helping Us Focus on Continuous Quality Improvements, Not Just Compliance
Compliance is just the ticket to the game. Quality performance improvement IS the game. Real quality improvements make companies more profitable. That’s because anytime you have to rework, retest, rebuild, and correct a product, your costs are going to pile up. That cost is exponentially higher when a defective product makes it out into the world.
Cloud QMS offers automated validation capabilities that replace four to eight months’ worth of traditional validation cycles with scripts that can be executed in a matter of days. Freed from the confines of system validation, pharmaceutical and medical device companies can improve products or processes, which translates into better compliance.
2. By Laying the Foundation for a Culture of Quality
Quality isn’t just ensured by quality departments. It’s a shared responsibility among all people and departments. In fact, ISO 9001:2015 goes as far as to define seven quality management principles that lay the foundation for a culture of quality: customer focus, leadership, engagement of people, process approach, improvement, evidence based decision making, and relationship management.
Integration and scalability, along with ease-of-use, can make cloud QMS the enabling technology that allows for cross-functional collaboration and shift focus from reactive quality to preventative quality. This will provide pharmaceutical and medical device companies bottom-line savings, and increased profitability and performance.
3. By Serving as the Platform Than Enables Industry 4.0
The rise of 3D printing, automation, cloud computing, IoT, personalized medicine, and other emerging technologies within life sciences presents both a challenge and an opportunity for quality teams. Patients, not companies, will shape how we create the products and services they rely on for health and well-being.
As manufacturing changes, products will feature extended capabilities around data collection that companies can analyze to refine products to meet their patients’ needs. Cloud QMS platforms will play an integral role by allowing companies to rapidly digitize and integrate processes horizontally across the entire organization.
4. By Improving Speed to Value and Lowering Total Cost of Ownership
Traditional enterprise applications are notoriously difficult to deploy and can take several months or even well over a year to launch. They require dedicated physical infrastructure and resources, and close coordination between IT staff, administrators, and business stakeholders.
Cloud QMS applications tend to have a smooth onboarding process. After you sign your subscription agreement, there’s a project kickoff meeting to help ensure both you and your partner are aligned with your quality objectives, and a comprehensive onboarding process leading up to your go-live date. Experienced vendors even provide shortcuts and best practices that can help you to launch your system faster and obtain greater benefits from day one.
In closing, cloud quality management software is making it both viable and advantageous for companies to make the switch to cloud from traditional on-prem applications. Early adopters will reap tremendous commercial benefits by shifting their quality costs from reactive to preventive, leading to cost-savings, better performance, increased profitability, and ultimately to happier and healthier patients. Check out TrackWise Digital QMS to learn more.
Brandon Henning is Director of Industry Solutions at Sparta Systems.
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