You use cloud-based software every day—think of the social media apps on your phone, or the document storage software you use. Cloud-based systems allow you to transfer and store a large amount of data instantly.
And it’s not just individuals who are leveraging the cloud. The 2016 IDG Enterprise Cloud Computing Survey shows that 70% of enterprise organizations have at least one application in the cloud, and on average, organizations invest $1.62 billion in cloud computing.
Motivations and hesitations when moving to the cloud
The top business goals driving cloud investments, according to the IDG survey are:
- Lowering cost of ownership
- Replacing on-premise legacy technology
- Enabling business continuity
However, there is still some hesitation when it comes to adopting large-scale cloud-based software for businesses. Implementation can be difficult due to training requirements, integration with existing systems, and cloud-based security. Putting your data in someone else’s hands is always a difficult position for a business. On top of all that, costs can quickly spiral out of control.
If you want to present the idea of switching to a cloud-based quality management system (QMS) to your medical device company, you’ll have to prove to your boss that it can meet your business’s needs as well as improve the bottom line.
1. Reducing costs and increasing profits
Regulation can be especially costly for the medical device community, and “millions of dollars are lost every year due to regulatory noncompliance issues and related lawsuits.”
But research shows that the long-term financial benefits of a QMS far outweigh the cost of deployment by streamlining some key processes.
- Managing compliance. QMS software increases compliance by cutting down on manual data entry, helping track customer complaints and resolutions, and automating reactions by assessing risk. The automated nature lets you get things up and running quickly and keep them going.
- Tracking and resolving supplier issues. A cloud-based QMS allows you to track supplier issues and products, giving you more clarity into your supply chain and allowing for quick corrective actions. You can even automatically manage supplier communications for corrective actions, giving your supplier more tools to help your company. More effective tracking and resolution of supplier issues means less back-and-forth communication and fewer preventable incidents.
- Upgrading and managing IT systems. SaaS solutions don’t drain IT resources like on-premise systems do. By moving to the cloud, your business can cut down on IT staffing, spend less on upgrading technology, and decrease security risks.
2. Reducing risk
With risk-based thinking present throughout the new ISO 13485 standards (such as selecting software based on the potential for a malfunction to cause damage), medical device manufacturers need to place an increased emphasis on reducing risk.
A recent study shows a 15% reduction in risk from using nonconformance management software and audits; similarly, corrective action boasts a 10% reduction in risk. This is possible because of improved:
- Reporting. Track items and link corrective actions, customer complaints, audit findings and nonconformances to reduce risk in impactful business areas.
- Decision-making. Use risk charts and data history to drive improvements and avoid high-risk decisions.
- Security. Cloud-based systems reduce the management of hardware and security internally. By moving into the cloud, your system decreases reliance on physical security, increases the quality of data backups, and has access to the most up-to-date encryption available.
3. Increasing productivity
A cloud-based QMS automates certain routine tasks. By auto-routing documents and setting up task and assignment notifications, you can spend less time searching for and processing information. Cloud-based QMS software increases productivity in the following ways:
- Instant, centralized communication rather than messy email chains
- Document control that saves up to 30,000 manufacturing hours a year, according to a recent study
- Instant access to all important data, which is stored in the cloud
For example, let’s say your manager comes to you in the middle of a busy workday and asks for a report on the number of open corrective actions in each of your manufacturing locations within the past month for an important meeting, which starts in ten minutes.
Without a cloud-based QMS, you would have to manually search through records, sort them by location, and compile a report—that could take hours. A cloud-based QMS, on the other hand, stores seemingly limitless data in one place, and will instantly generate a report broken down by date, location, or any other criteria you may need.
The bottom line: Achieving operational excellence
To really get decision-makers on board with implementing a cloud-based QMS, you need to show them that it allows you to go above and beyond basic compliance requirements. Instead of treading water in compliance, you can focus on process improvement techniques such as:
- Standardizing processes through automated workflows and notification systems
- Creating closed-loop workflows, which continuously monitor process and risks while tracking resolutions
- Tracking key performance indicators (KPIs) in real time
- Breaking down silos between locations or even departments within a location through increased process transparency and automated, cross-team workflows
Conclusions and key takeaways
As you build your business case for cloud-based QMS software, keep the following tips in mind:
- You can’t start enjoying the benefits of a cloud-based QMS until everyone sees the value in it. “User buy-in is probably one of the more major contributors to the success of any implementation,” says Tim Lozier, Director of Product Strategy at Verse Solutions, a cloud-based QMS.
- To get everyone on board, stress the bottom-line business benefits rather than the technical features. People are generally more interested in how something can improve their daily tasks and the business overall, rather than just what the software is capable of.
- Keep your language simple and universal.