In February, we published a blog series titled EQMS for X. This series of posts focused on the need for automating quality and compliance processes across sectors. We created a collection of seven posts covering the role of a next-generation cloud-based EQMS in manufacturing, lifesciences, CPG, hi-tech, cannabis, aerospace and automotive sectors.
In this blog, we focus on the need for a robust quality & compliance process at medical device enterprises. We recently published a whitepaper titled ‘A 7-Step Guide to Quality & Compliance for Medical Devices Companies’.
The paper suggested a 7-step framework to build a robust EQMS process, which is especially relevant for the medical device landscape. Here’s a snapshot of what we suggested:
- Step 1: Understand the regulatory landscape
- Step 2: Design your Quality & Compliance Process
- Step 3: Benchmark against industry best practices
- Step 4: Design standard operating procedures
- Step 5: Create a Master Quality & Regulatory checklist
- Step 6: Quality Analytics to derive insights from Quality Data
- Step 7: Continuous Improvement
While product recalls and stringent FDA guidelines are one reason to build a top-notch quality process, there is no doubt that quality can deliver competitive advantage in the medical device space. While R&D is critical, the ability of a medical device company to scale depends on manufacturing prowess, high levels of focus on customer service and a relentless pursuit of excellence. This is possible by adopting an unflinching focus on quality in every step along the way.
At ComplianceQuest, we have helped 100+ customers in the life sciences sector build a robust quality and compliance process. Built on the Salesforce.com platform, ComplianceQuest is built from the ground up for the cloud, and we offer a secure, scalable and flexible platform for our clients.
Here, we share a few testimonials from our customers and share reasons why they chose ComplianceQuest:
A world-leading manufacturer of miniature motors serving the medical device industry chose ComplianceQuest for automating quality and compliance across the board. The company is starting with implementing the following solutions: Document, Supplier Management, Change, CAPA and Training.
3 Reasons Why we clinched this deal:
- There was no need for an IT Team to implement the solution. It worked off-the-shelf.
- The CQ product was extremely user-friendly, intuitive and end-to-end, and we delivered a great early user experience.
- CQ has been built on the Salesforce.com platform, which enables easy integration with other products used by the company.
To share another example, another leading digital health products company had evaluated more than five EQMS products. The company was looking for an EQMS product built on the ‘Real Cloud’ and one that was highly secure and scalable.
3 Reasons Why we clinched this deal:
- Scalable Document Management Module: The client wanted a best-in-class document management system to migrate 50,000+ documents. CQ’s product came out on top among all the competition. The client was thrilled with the ease of migration, rich features and intuitive user interface.
- Integration with existing systems: The CQ product was easy to integrate with the client’s homegrown Oracle-based systems. In fact, it was the “best product that allowed seamless integration” said the client.
- Supplier Management Process: CQ’s product had inherent features to capture supplier ratings and included a scalable platform to capture key metrics of a large number of suppliers. This was an important feature the client was looking for.
There are several reasons why medical device quality leaders choose ComplianceQuest. You should come check out the CQ platform for your specific needs. Request for a demo here: www.compliancequest.com