Unlike some industries that experience less regulatory pressures and aren’t as closely tied to health and well-being, quality management in life sciences is in many ways mandated by entities like the FDA and expected by consumers. Ensuring quality, however, is easier said than done, especially for large (more than $1 billion in revenue), mature life sciences companies that boast a global footprint comprised of contract manufacturers, suppliers, partners, and distributed facilities.
With the acquisitive nature of the industry, alongside a history of often disparate IT investments, many of these companies face a disconnected set of quality management data sources and systems that aren’t delivering nearly as much value as they should. However, reliance on such IT strategies has been decreasing in the past decade as adoption of Enterprise Quality Management Software’s (EQMS) standardized, centralized, and automated quality processes is on the rise.
Today's global life sciences companies require EQMS's robust, comprehensive suite of quality functionality, but with such a wide landscape of vendors, which ones should executives be focusing on? This post aims to answer that question.
Any solution selection should include a good combination of different types of vendors, the old stalwarts as well as up-and-comers. The EQMS space for life sciences is no different and can be considered quickly maturing and expanding. There are many innovative, up-and-coming vendors focused on serving small-to-medium sized businesses as well as veterans.
The up-and-comers generally specialize in some area (or a combination of areas) such as document control, regulatory filing, or corrective and preventive actions (CAPA). There are also a number of ERP, PLM, and MOM vendors that have invested over the past several years to start delivering EQMS capabilities as an extension of the existing platform. Although this article is focusing instead on the EQMS industry veterans, these other vendor options are compelling and should not be ignored. More can be learned from our previous post: 9 EQMS Vendors to Watch in Life Sciences.
In addition to these up-and-comers, there are a number of industry veterans that stand out in the EQMS space for life sciences and should form the basis of a solution selection. In the past several decades, these vendors have built a deep expertise in delivering functionality that enables quality communication and collaboration across the entire product lifecycle. For quality executives currently considering solutions providers, the list below is a good place to start.
(Listed in no particular order)
With over 500 customers today, in the past twenty years MasterControl has evolved from a document control software provider to a leading EQMS provider. It serves a range of company sizes across pharmaceuticals, medical devices, and blood and biologics. However, its primary focus is in on enterprise-wide implementations for complex global organizations, and the company leverages its worldwide employee base to support such implementations.
Launching its process-centric and cloud-based platform in the past decade, the solution covers a diversity of quality management software functionality for managing risk and compliance at a large scale. In addition to many standard EQMS functionalities, MasterControl delivers complementary solutions for PLM, LIMS, ERP, and MES, as well as for connecting and collaborating with partners and suppliers.
Although it serves numerous industries, in the past twenty years Sparta Systems has built a strong EQMS solution for global life sciences companies. TrackWise, Sparta Systems’ EQMS offering, was created to be highly configurable, providing the flexibility needed to meet most organizations’ quality management needs without significant resources.
With a long-running presence in Tier-1 pharmaceuticals and now growing in medical devices, biotechnology, and blood services as well, Sparta Systems’ recent change in CEO has only aided the organization in diving deeper into each of these subverticals. In our last briefing with Sparta Systems, we heard about investments in business intelligence, mobility, and its GUI, and expect to see news about those product enhancements in the near future.
With more than 20 years in the EQMS space and strength in food and product safety, EH&S, and quality risk management, EtQ has carved out its place as a leading solutions provider for automotive, aerospace and defense, and general manufacturing. More recently, the solutions provider has moved into medical devices, as well as into biotechnology, blood services, and pharmaceuticals.
We see EtQ as one of the most innovative and fastest growing companies in the EQMS space. With its continued investments in emerging technology—cloud and mobility—and its modular implementation approach, EtQ has been able to meet the needs of both SMB customers as well as larger enterprises in life sciences.
QUMAS has been an increasingly stronger player in the EQMS space since 1994. It specializes in solutions for compliance management, collaboration, document management, and quality management for life sciences organizations, and has strength in serving biopharmaceuticals, medical devices, and pharmaceutical manufacturing. Its focus on life sciences-specific collaboration capabilities is of particular note and LNS expects this to be a continued area of strength and innovation over the coming years.
In late 2013, the vendor was acquired by scientific software company Accelrys. QUMAS’s on-premise and cloud-based solutions will complement Accelrys Scientific Innovation Lifecycle Management (SILM) offerings, providing a well-rounded solution for life sciences companies from the innovation phase through the product lifecycle. We’ll be keeping an eye on this acquisition throughout 2014 to provide readers with updates.
A long-time player in life sciences, Pilgrim Quality Solutions excels at managing quality processes while ensuring regulatory compliance and mitigating risk. Its solution, SmartSolve has been deployed by both medium and large global life sciences organizations, particularly in medical devices, pharmaceutical manufacturing, biotechnology, and blood and tissue. In recent years Pilgrim Quality Solutions has redoubled its focus and efforts on the life sciences industry and developing industry-specific capabilities, which should pay dividends in the coming years for existing and new customers.
In line with other vendors, Pilgrim Quality Solutions is focused on quality management from product ideation through service. The release of its offering added configuration capabilities for its workflows, data entities, and forms, as well as process harmonization for enterprise roll-outs. In the past seven years, Pilgrim Software has been positioning itself as a leading provider of cloud-based EQMS solutions.
For more information on EQMS providers, read LNS Research's EQMS Solution Selection Guide.
Those are our thoughts on some of the top EQMS vendors for global life sciences organizations. If you're currently evaluating one or more of these solutions, or are just starting your EQMS journey, please feel free to comment below, email us, or tweet to us @LNSResearch for more information.
Learn about QUMAS's ProcessCompliance and Compliance SP solutions in this excerpt from LNS's EQMS Solution Selection Guide.
Learn about the motives behind Accelrys' acquisition of enterprise quality management software provider QUMAS and what it means for life sciences.
Read about LNS Research's experiences at the Connect 2014 user conference, and how leading companies are addressing challenges with collaboration.