Learn about Pilgrim Software's SmartSolve solution and how the EQMS solution provider is helping life sciences companies close the quality loop.
The Enterprise Quality Management Software (EQMS) space continues to mature and there are many solutions providers, each of which with different strengths and expertise. It is no surprise that with the direct effect on health and safety of the public at risk, the regulatory burden specific to life science organizations is a relentless challenge in the context of quality management throughout the value chain.
EQMS implementation is strong in life sciences sub-verticals, with 22-25% of respondents to an LNS Research survey indicating they have already deployed a solution. Significantly more are in planning stages with 6-7% having allocated budget.
During a recent session with the newly rebranded Pilgrim Quality Solutions, headquartered in Tampa, Florida, LNS Research was introduced to some of the latest approaches to the implementation of and enhancements to the company’s platform. New capabilities that have been designed to build on and improve the established core functionality relating to regulatory compliance and risk mitigation.
With more than 20 years of experience, hundreds of customers and a legacy of delivering robust quality management solutions primarily but not limited to life sciences organizations, Pilgrim launched this next generation platform, SmartSolve, in 2012. This step-change in flexibility of the solution including the ability to configure modules from the ground up created a challenge for existing customers as seen with many vendors in recent times. Having navigated these challenges and acknowledging some bumps along the way, recent releases have demonstrated a renewed focus and significant new capabilities including newly developed change management, enhanced supplier quality management, and analytics capabilities.
Pilgrim Taking on New Ground
With a re-organized management team and palpably recalibrated focus, the veteran provider is taking on new and interesting ground. The first example of which is the bold, guaranteed, 30-day go-live program known as ‘SmartStart’. It is exactly as stated by the name whereby an individual module of the solution can be deployed based on a pre-configured (out-of-the-box) set of best practices (for roles, security, decision trees, documents etc.) in the subscription based, single tenant (separate database) private (enterprise) cloud. What is of particular importance is the inclusion of validation (Installation Qualification, IQ and Operational Qualification, OQ) within the 30-day window.
Validation is not a simple pursuit and can in itself cause major issues for an organization that implements EQMS. This is an area where Pilgrim exudes confidence and even provides a hotline for its customers during regulatory encounters post-implementation to ensure support reflecting the nuances of the regulator’s requirements.
Given that more than 80% of Pilgrim’s customers are in the life sciences domain and a significant proportion of those are medical device manufacturers, the looming August 14, 2015, date is of particular importance. This is the effective date for the mandatory requirement for electronic Medical Device Reports (eMDRs) as required by the U.S Food & Drug Administration (FDA). It is not new for the FDA to require that “Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices”. What’s new is the method, mandatory submission via the FDA’s Electronic Submissions Gateway (ESG). Pilgrim has incorporated eMDR capability into the SmartSolve offering and has been involved in the pilot program with the FDA’s ESG since the pilot phase opened.
Quality as a Strategic, Competitive Advantage
Pilgrim aims to help companies view quality as a strategic asset and competitive advantage. SmartSolve’s focus is on ensuring regulatory compliance and quality from product ideation through the manufacturing process and beyond. The integration between different modules facilitates the sharing of information and development of closed-loop quality management processes. The recent introduction of an analytics layer beyond the previous standard reports library rounds off the strategic asset approach.
Through a partnership with TIBCO, Pilgrim has introduced the SmartSolve Business Intelligence offering. Though initially limited to audit performance, non-conformances and CAPA, this move demonstrates the commitment to provide a flexible layer for powerful insight that can drive tactical and strategic decision making for quality leaders. Ultimately, driving a less reactive and more proactive approach across an organization with dashboards as vehicles to consume the information if desired.
The combination of the fast-track implementation guarantee and the partnership for advanced analytics specifically demonstrates a desire to lead. Other vendors have programs to accelerate implementation within certain parameters, also restrictions applicable to Pilgrim’s guarantee, but these are not productized typically. Pilgrim is among the leaders in EQMS based on their recent roadmap delivery and expanding their analytics offering is one key to remaining there. Mobility is one area where challenges beyond using the application in a ‘connected’ environment on a tablet may not suffice in the long term. An ‘app’ for audits is planned and offline capabilities are under consideration.
We expect Pilgrim Quality Solutions to continue investing in its platform, both in the depth of SmartSolve’s functionality and in its cloud-based capabilities. As the company is intent on closing and tightening the quality loop in the coming years, it’s likely that the market will see improvements to the solution’s mobility and expanded analytics offering. Future posts will dive deeper into the overall capabilities of SmartSolve and the platform will be included in the forthcoming solution selection guide in 2015..