While R&D and new product development remains the core of most medical device companies, digital transformation using relevant software solutions has played an important role in increasing efficiency and quality, keeping customer satisfaction in mind. Also, the need for regulatory compliance across the entire supply chain cannot be emphasized enough. It has become paramount to have a 360-degree view of processes not only within their organization but in that of their partners along the supply chain as well.
While investing in a quality management system has become inevitable for medical device manufacturers, they face challenges here too – right from selecting the right QMS to maintaining and leveraging it. On-premise quality management systems need dedicated resources – both in terms of IT infrastructure as well as people – and this certainly adds to more costs and additional responsibilities.
Six causes for concern for organizations with regard to implementing QMS solutions include:
- Flexibility: Though QMS systems provide information on quality events for taking corrective action, organizations need it to be automated. This requires a flexible workflow that can be adapted to the organization's existing processes, reflecting changes simultaneously without the need for intervention. Otherwise, the cost of adapting the system to synchronize with the organization's processes can be exponential.
- Focus on Core Businesses: The device manufacturers need to be focused on the’ design to delivery cycle’ of the devices they manufacture. A QMS should aid this but can often take away attention in making sure the system is functioning as expected.
- Total Cost of Ownership: Investing in an on-premise QMS may seem like the answer to all problems. However, with time, they need to be updated and corresponding investment in suitable hardware as well. As new technologies enter the market, businesses may be compelled to abandon existing solutions.
- Scalable Solution: As organizations grow, they need their software also to be able to keep pace without any compromises to its functionality.
- Greater Visibility into Data: The increased interconnectedness between devices and organizations has also increased the volume of data coming in, making visibility difficult. The QMS system needs to be capable of culling out relevant data and provide insights through reporting tools.
- Security: With the threat to data and privacy on the rise, businesses also need to continually upgrade their protection and invest in security solutions, upgrading them with every new potential threat in the horizon.
Tapping into Cloud
Cloud services have transformed the way organizations are leveraging IT solutions, offering a software-as-a-service (SaaS) model where users can pay per user per month. It makes immense sense for medical device manufacturers to opt for an enterprise-ready QMS built on the modern cloud.
An EQMS on the cloud can provide flexibility by allowing organizations to customize the configuration of keywords, logins, and pages as per their needs. The cloud-based QMS solution from Compliance Quest, for instance, includes graphical tools that make it easy to drag and drop, doing away with the need for programming knowledge. It provides speed like in-house servers never can, and the expandable memory provides room for increasing computing power as and when there is a need.
CQ's cloud-based delivery model is also designed to eliminate the administrative burden on its clients, enabling them to focus on their core business rather than worry about day-to-day operations of a QMS. The solution is also scalable as it is modular, and users can access features as needed, paying accordingly.
As a result of accessing the QMS on a pay per use model, the total cost of ownership is lowered. Further, businesses do not have to be limited by hardware constraints or bandwidth requirements.
Our in-built reporting tools can be used to create report templates, schedule reports with drill-down capabilities when needed and create reports in minutes. This will enable organizations to leverage the data they generate and have access to insights better, improving decision-making and creating business strategies.
Of course, as with any cloud based product, the decision to transition to a new product, upgrade to an advanced plan, adding more users - all become easy.
Implementing and deploying a product like ComplianceQuest is remarkably easy, with no need to specific upgrades to hardware or software. There is no upfront investment, and you move from either a manual, excel sheet process or an on-premise solution to ComplianceQuest in a matter of hours.
Additionally, with a cloud-based QMS solution, the security is also the responsibility of the service provider and assured. Geographically disparate teams can collaborate better on secure platforms, jumpstarting the compliance efforts of the businesses. This provides for increased agility of businesses as users and storage can be added based on growth needs, making it immensely scalable.
Without a doubt, CQ's cloud-based QMS solution built on the Salesforce.com platform, lets businesses focus on their strengths while silently contributing to their growth, compliance, quality and cost control needs remotely, and yet closely integrated to the business processes.
The appexchange platform has in-built features for security, reporting, data validation, and integration with other SaaS products, while also having the ability to customize as per a client’s specific needs.