Introduction: Going Beyond Lean and Six Sigma
SPR Therapeutics, a fast-growing medical device manufacturing company specializing in neurostimulation technology, offers a revolutionary approach to drug-free pain management. Founded in 2010 and headquartered in Cleveland, Ohio, SPR Therapeutics is a privately held company dedicated to providing a new standard of care. Their flagship product, SPRINT PNS, offers safe and effective pain management options to treat both acute and chronic pain without the use of opioids or invasive surgeries.
In 2016, SPR Therapeutics received FDA clearance for its SPRINT PNS product. With the goal of increased market penetration, they pivoted their focus from solely an R&D company to a blend of research and product sales. SPR Therapeutics’ customers include hospitals, surgery centers, and pain management practitioners.
The company was using a combination of manual processes and legacy software to manage the quality management workflow. According to the company’s Director of Regulatory Affairs and Quality Systems, this proved to be a major bottleneck. It was adding complexities and inefficiencies into not only the quality management workflow but the overall product lifecycle.
Key Benefits of Migrating to a Cloud-based QMS
The quality leader soon realized that the only way to do this right would be to migrate to a next-generation, cloud-based EQMS for the following reasons:
- The company was scaling fast and it was critical to embrace digital transformation and automation to drive operational excellence.
- It needed a next-generation EQMS that would seamlessly integrate with its ERP and CRM. (SPR Therapeutics decided to go with ComplianceQuest for EQMS, Salesforce for CRM and Rootstock for ERP).
- There was a crying need for an integrated system to automate complaints handling, document control, calibration, inspection, and training.
- Quality analytics with world-class dashboards and data visibility across the product lifecycle would drive continuous improvement of quality management processes.
- FDA compliance and all other regulatory requirements had to be automated.
- An integrated system connecting the EQMS, ERP, and CRM was key to handling complaints with agility.
For SPR Therapeutics, migrating from an on-premise system to the cloud was critical to improving both quality and compliance. It also ensured that the quality team and other stakeholders saved valuable time and became more productive.
8 Reasons Why You Must Migrate to a Cloud-based QMS
# 1- You should have migrated “yesterday”
Moving your QMS to the cloud is the first step to “staying current” and taking advantage of the latest technologies. The future of quality management will revolve around using data, AI, ML, and NLP to drive efficiency and continuous improvement. You need a system that’ll automatically “predict” risk levels and the urgency of a complaint. You need a QMS, that’ll automatically trigger a CAPA in case of a non-conformance.
Modernizing your QMS holds the key to be future-ready. It’ll help you “stay current” and use emerging technologies like AI and advanced analytics to build a continuously improving QMS.
# 2 – You need a scalable, sustainable solution
To meet your organization’s growth needs, you need an EQMS that is easy to scale in terms of no. of users and no. of locations. It should also be easy to add functionality and modules.
For example, a company may start with automating document management, audits, and inspections. Over time, it may want to automate complaints, training, CAPA, change management, and equipment management. With an EQMS like ComplianceQuest, which is built from the ground up for the cloud, adding modules and solutions is done with ease.
It is also important that even as your system scales, your infrastructure costs are under control.
Several quality leaders believe that implementing a cloud-based EQMS is more sustainable in the long run. Ease of product upgrades is critical to meet evolving compliance requirements.
One of the biggest challenges with a legacy, on-premise QMS is that it is inefficient to upgrade the product or add features. It is also more expensive in terms of infrastructure costs.
# 3 – It’s better in terms of data visibility and traceability
A modern QMS is designed to seamlessly integrate people, information, and processes. It must be designed for easy flow of information across the enterprise.
One of our customers, Mustang Bio, is a clinical-stage biopharmaceutical company that manufactures next-generation therapies for hematologic cancers, glioblastoma, and rare genetic diseases. The company decided to migrate to a cloud-based system to address several challenges including the following:
Data traceability and searchability of information was a huge challenge long time to implement CAPA and non-conformance changes Document storage was unwieldy and expensive
With a cloud-based EQMS, quality leaders are able to connect the ERP, CRM, EQMS, and EHS to offer a unified system to manage all processes across the organization. The EQMS becomes a single source of truth for all quality data. Additionally, it also serves as a system of collaboration, so it is easy for multiple stakeholders to work as a team to drive change management, CAPA, and other efforts.
With a cloud-based EQMS, you can connect your suppliers and partners into your QMS workflow. This is especially important in sectors like manufacturing, life sciences, and medical devices where supplier quality directly impacts quality performance.
# 4 – Flexible and customizable
Every enterprise is different when it comes to quality processes and workflows. A modern QMS allows you to customize the product as per your business needs.
For instance, to automate complaint handling at SPR Therapeutics, a standalone complaint management solution wasn’t enough. The complaint intake process was inside Salesforce CRM which integrated with ComplianceQuest EQMS. Various solutions that are part of the ComplianceQuest platform including document management, CAPA, and change management are connected as well. The entire system was also connected to Rootstock ERP, allowing for any automation needed in terms of resource planning or inventory management.
A SaaS-based product like ComplianceQuest is flexible and easy to customize when compared to on-premise options. The time taken to implement custom processes is also usually lesser with a cloud-based platform.
# 5 – Secure collaboration
ComplianceQuest EQMS + EHS (QHSE) has been built from the ground up on the Salesforce platform. This allows us to leverage Salesforce Shield which offers enhanced protection, monitoring, and retention of your critical data stored in the ComplianceQuest platform.
Key features of Salesforce Shield include native encryption, thorough data monitoring, and the ability to define custom security policies for your enterprise. This ensures that all automation and collaboration happen securely.
ComplianceQuest leverages Salesforce Shield to ensure that all collaboration and flow of information happens with encryption and pre-defined security measures.
# 6 – Anytime, anywhere access
Across the product lifecycle, decision-makers need real-time access to data and information. A truly automated audit and inspection process must allow quality professionals to enter data from their mobile devices. In the case of on-premise solutions, mobile capabilities are often clunky and slow.
Mobile-ready features are real game-changers when it comes to quality management and compliance. It helps quality professionals act with agility.
# 7 – Easier from an IT resource perspective
On-premise quality management systems require dedicated IT resources within your enterprise for ongoing upgrades and maintenance. This not only adds to the cost but also increases complexities. It is also not easy to recover from disasters and your enterprise IT team needs to ensure it is “always available”.
On the other hand, a cloud-based QMS is easier to maintain and the Total Cost of Ownership (TCO) is lesser because it does not require a dedicated IT team.
A cloud-based QMS reduced your Total Cost of Ownership (TCO) and is also easier to manage in terms of upgrades and maintenance.
# 8 – Fully validated environment
Highly regulated industries like healthcare, medical device, and life sciences require that all software is hosted in a fully validated environment. This means that your platform must comply with necessary data protection and other regulatory requirements.
It’s easier and more cost-effective to maintain a fully validated environment to meet the requirements of regulatory authorities with a cloud-based QMS.
In our next blog as part of this CQ Guide Series, we’ll focus on how to migrate to the cloud.
This innovative manufacturer of zippers ditched its legacy QMS to migrate to a modern, cloud-based solution.
Read this case study of Tokyo-based YKK here.
