Life Science Companies are Seeing the Value of Moving to a Cloud-based QMS that is Scalable in Support of a Much Needed Digital Transformation in the Industry
By: Sandra K. Rodriguez, Market Analyst
The Sparta Systems management team recently briefed Axendia on the newly unveiled TrackWise Digital cloud quality management system software platform. The company, founded in 1994, has undergone several key changes as of late such as a recent acquisition by private equity group New Mountain Capital, and new executive leadership in Dana Jones, CEO and Vinit Doshi, COO who both joined the company earlier this year.
In addition to TrackWise Digital, Sparta still offers the solution it is perhaps best known for – TrackWise, an enterprise QMS platform. Although it is a traditional on-prem application, Sparta offers extended cloud capabilities such as quality event intake and supplier collaboration by utilizing a hybrid architecture and seamless user experience.
“Sparta Systems has been a leader in quality management software for the pharmaceutical, medical device, consumer product, and discrete manufacturing industries for over decades. In 2016, Sparta acquired cloud QMS platform 123Compliance, and following a two-year period of heavy investment, rebranded the platform as TrackWise Digital to signal that in our view, it is now equal to our legacy TrackWise platform,” said Brandon Henning, Director of Product Management for TrackWise Digital.
“In addition to core quality capabilities like audit, CAPA and change control, TrackWise Digital has grown to offer complaint handling, document management, training management, and supplier quality management. The investment has paid off for us as we’ve been able to quadruple the number of clients using TrackWise Digital from the original twelve to well over fifty,” said Henning.
TrackWise Digital employs a hybrid architecture. It is multi-tenant at the platform level, and single-tenant at the configuration and data control level. This allows companies to pull, accept and validate new versions at the time that is most optimal for them. This approach also seems to be more amenable to companies with complex change management processes who are unable to keep up with validation activities around pushed software updates common in Cloud Native, multi-tenant applications. The only potential downside to this approach is that it can lead to the same issue plaguing companies with on-premises installations: various versions of the software throughout the enterprise or the potential to fall so far behind on the latest version of a software that it would require a major upgrade, validation and change control. The pushing of updates ensures that customers remain on the latest version of a software and that patches or bug fixes are applied in a timely manner.
To minimize validation burdens, the company offers “Sparta SaaS Validation.” Services include:
- Pre-configured solutions based on industry best practices are validated each release.
- Updated and re-executed validation scripts each release.
- Validation documents provide time savings for developing customer configurations.
- Protects from pure cloud given regulatory validation cycle.
To further reduce the burden of validation, each release of TrackWise Digital comes with an executed standard validation package including:
- Validation Plan
- Functional Specification and User Requirement Specification
- Installation Qualification
- Operation Qualification
- System Qualification
- System Design Specification
- Traceability Matrix
- Validation Summary Report
“The rapid growth of Trackwise Digital’s user base over the past two years has come from net new customer acquisition as well as helping our established customer base transition from on-premises to SaaS as and when they’ve indicated they were ready. There’s also an incredible variety in the size of each deployment, from smaller clients who average just a handful of users, to one large client who has onboarded over 5,000 users on the platform,” said Henning.
According to Sparta, while every TrackWise Digital implementation includes a service engagement from the Customer Success Team, nearly half of its customers are leveraging out-of-the-box functionality and industry best practices to reduce implementation validation time and costs by as much as 75%. On the other hand, larger and more mature organizations continue to require configuration of customer specific data fields, form layouts and process flows.
Leveraging the Salesforce AppCloud Infrastructure as a Service (IaaS) platform, Sparta now offers TrackWise Digital. This is a single tenant model where each customer accesses a dedicated instance hosted on Saleforce.com.
This single tenant approach is aimed at companies with complex change management processes unable to keep up with validation activities around pushed software updates common in Cloud Native multi-tenant applications.
The number of net-new customers that Sparta Systems has acquired over the past two years is a clear indication that Life science companies are seeing the value of moving to a cloud-based QMS that is scalable in support of a much needed digital transformation in the industry.