Pilgrim Quality Solutions: The Path to Enterprise Quality Management

Rick Lowrey, CEO and Charles Murphy, Senior Vice President Pilgrim Quality Solutions (“Pilgrim”) knows quality. The company is equally proficient at supporting its customers’ regulatory compliance requirements. Pilgrim has been perfecting the art of Quality Management Systems (QMS) for over two decades– delivering and implementing quality and compliance management solutions for quality-minded companies around the globe.

Pilgrim itself is ISO-certified as a company, meaning that as a QMS solution vendor, it abides by and is audited against fully documented Standard Operating Procedures (SOPs) and quality processes and procedures, every day across the entire company. The company even goes beyond development and QA testing of its solutions–validating both its platform and all of its solutions before releasing them to the market. By design, Pilgrim delivers a platform for quality, and a comprehensive and validated end-to-end suite of modular, yet integrated, quality and compliance management solutions–all with the goal of benefiting the market and customers, and serving 1,000,000+ users in over 30 countries around the world today.

Future Market Insights, a leading market intelligence and consulting firm, recently reported that the leading industries focused on implementing QMS solutions are Healthcare and Life Sciences organizations. Market adoption by Life Sciences companies, which Pilgrim has focused on and to which is a dominant solution provider, is due in part to the industry’s regulatory complexity across countries where one manufactures and distributes products, as well as to the industry’s changing regulatory and business requirements. Organizations are increasingly adopting QMS solutions to not only ensure compliance, but also to simultaneously drive efficiencies and cost savings while dealing with new product introductions, innovations, and industry consolidation.

The Path to Enterprise Quality Management (EQMS)

The need for business harmonization and integration across business processes, across divisions, and across a company’s multiple sites around the globe are driving platform decisions for enterprise quality management systems (EQMS); at the same time, scalability, usability, flexibility, infrastructure, and support cost efficiencies are driving the migration and cloud-adoption of QMS and EQMS like never before.

Pilgrim is one of the longest-tenured vendors in the QMS market, first entering the market in 1993. Some of its more than 500 customers are quality-focused companies outside the Life Sciences industry, including leaders in consumer goods, automotive, aerospace & defense, logistics service providers, government agencies, and other regulated industries. However, Pilgrim is extremely focused on the quality and regulatory requirements of Life Sciences industries, including those companies involved in the manufacturing and distribution of pharmaceuticals, medical devices and combination products, as well as biotech and clinical companies.

From its origins deeply rooted in the quality movement of the 1990s to its domain expertise gained over more than two decades since, Pilgrim has cultivated the elements that comprise today’s leading quality and compliance management solutions. In interviews, its customers and industry analysts consistently communicated that Pilgrim was selected over other alternatives based on three key strengths: the Pilgrim Solutions, the Pilgrim Platform, and the Pilgrim People.

Pilgrim Solutions–Solutions for Quality and Compliance

Pilgrim’s years of life sciences and supply chain domain expertise are manifested in its SmartSolve® product suite.
The suite’s packaged “in-the-box” quality and compliance management solutions, with built-in industry best practices, meet the regulatory and business workflows, forms, controls, electronic signature auditability, and reporting requirements, and they are continuously updated to address evolving regulatory standards. Pilgrim’s modular, yet integrated, solution approach affords companies the flexibility to implement SmartSolve solutions using a phased approach. This enables customers to focus on the area of greatest need or importance, or largest quality risk or challenge areas, and then expand into other quality and compliance areas over time, providing an end-to-end platform for enterprise quality and compliance management.

The most frequent paths for companies wishing to improve the automation of their quality and compliance processes include the following SmartSolve solutions: Document & Training Management, Nonconformance/Deviations & Corrective Action/Preventive Action (CAPA) Management, Complaint Management, or Supplier Quality Management. Other top initiatives that Pilgrim SmartSolve addresses include: Audit Management, Change Management, Out of Specification (OOS) Management, Recall Management, and Equipment & Inspection Management. All of the solution modules are easy to use via an intuitive common user interface (UI) that enables cross-functional adoption.

SmartSolve includes all the required operational and mandated compliance reporting capabilities that a company needs. It also includes built-in standard Quality Intelligence dashboards to guide a user to areas that need attention or to the work that needs to be performed or followed up on.

Pilgrim Platform–The Complete Compliance Platform

The Pilgrim Platform is the foundation and backbone for Pilgrim’s SmartSolve Solution suite. The purpose-built compliance platform provides not only a secure and highly scalable operating environment, but a highly productive rapid development environment that is leveraged across operational functions. The Pilgrim Platform allows Pilgrim to efficiently run multiple simultaneous Agile Development Sprints and initiatives in a timely manner and with ease, to deliver new roadmap development projects as well as enhancements to existing modules and processes. This progress is accomplished at a predictable and controlled cadence that delivers maximum value to its customers. Its architectural design and built-in market-leading Automated Validation capabilities aid companies’ ability to easily implement as well as upgrade to new releases over time.

The Pilgrim Platform also offers built-in internationalization capabilities, the ability to support complex organizational hierarchies, as well as the inherent integration between multiple Pilgrim modules and the ability to easily integrate with other enterprise and best-of-breed systems. The Pilgrim Platform supports a core browser-based user experience as well as Pilgrim Mobile capabilities. Pilgrim Mobile includes mobile apps as well as extended enterprise user interaction. Supplier connectivity and enterprise-wide collaboration can be accomplished via web-form input or secure portal exchange processing.

On top of the strong underlying technical foundation of the Pilgrim Platform are a series of SmartDesigners–platform tools that allow for client-specific configuration of the behavior and operation of the solutions without the need for custom modification, thereby preserving the quality and support, and the ability to upgrade Pilgrim solutions. The Pilgrim SmartEntity Designer allows extensibility of client’s data needs.

The Pilgrim SmartForms Designer allows for intelligent configuration of the user interface (UI) and interaction behavior that can be user- or role-specific.

Pilgrim in the Cloud–Today’s Deployment Option of Choice

A company’s quality maturity, risk tolerance, business complexity, and user adoption are key drivers in determining the focus and path that a company will take on their QMS journey. Companies are also influenced by their desire to standardize on a platform for quality and compliance, one that they can use to harmonize data and processes across divisions and sites globally, and a more scalable and cost-effective deployment method. Pilgrim addresses all of these points, including today’s clear deployment option-of-choice, “the cloud”.

Pilgrim has offered its solutions in the Pilgrim Cloud for nearly a decade, and today it is the recognized leading provider of cloud-based QMS. Some of the world’s largest Fortune 50 customers have selected the Pilgrim SmartSolve Solutions and the Pilgrim Cloud over traditional in-house, on-premise, or other cloud deployment options. The Pilgrim Cloud is a highly secure and validated environment with protections and safeguards over client data and system reliability. Cloud-based SaaS solution pricing includes all hardware, operating systems, databases, and related data center infrastructure costs, as well as the associated monitoring, support, tuning, and upgrades. Pilgrim Cloud customers also experience the added value of Pilgrim’s Managed Services which provide operational support, maintenance, and solutions upgrades. When a customer chooses to deploy a SmartSolve solution in the cloud, Pilgrim also performs the necessary installation qualification (IQ) and operational qualification (OQ) validation, and provides performance qualification (PQ) scripts as well.

Pilgrim SmartSolve Solutions are equitably priced for small-to medium-sized companies as well as for the largest multi-division Fortune enterprise leaders. Bundled or individually licensed solutions, and user-based pricing, combine for affordable software-as-a-service (SaaS) subscription pricing, and allows for companies of all sizes to expand their use of modules and/or users as they evolve their QMS maturity. SaaS pricing includes all Pilgrim Cloud hosting and infrastructure costs as well as Pilgrim Managed Services and Support costs for the licensed solutions.

Pilgrim People–Trusted Compliance Partners

Behind its SmartSolve Solutions and Platform is Pilgrim’s domain expertise and a service and support culture that differentiates it from others in the software industry. The original Pilgrim team was an assembly of cross-culture, cross-discipline professionals, and today’s expanded team is no different. Vast life sciences and supply chain domain expertise, coupled with more than two decades of quality and regulatory expertise, allow Pilgrim to go beyond simple project management and implementation services, to deliver best practices and keep its solutions up to date with regulatory changes in the industry.

Pilgrim and its customers also benefit from the leverage that an extended ecosystem of partners provide. Additional systems integration (SI), organizational change management, data migration, and global rollout services are provided by leading firms Deloitte, Cognizant, Tata, Capgemini, and others. Together, customers, partners, and Pilgrim create a strong triad for program/project management and implementation and rollout success, where and when needed, to achieve operational productivity and desired improvements.

Pilgrim Quality Solutions

Tampa, FL

Rick Lowrey, CEO and Charles Murphy, Senior Vice President

Pilgrim is a leader in quality and compliance management software and services for Life Sciences

Pilgrim Quality Solutions