Quality Management Case Studies
Hundreds of companies of all sizes are transforming their businesses with Pilgrim Quality Solutions. Discover through the following Life Sciences case studies and success stories how Pilgrim is helping organizations achieve their quality goals and comply with quality management regulations.
Without a standardized platform for critical management needs, highly regulated manufacturers face multiple challenges to their quality and compliance objectives. Read how one Life Sciences company evaluated and implemented an On-Demand enterprise solution for quality, compliance, and risk management to help unify its processes across its global network. And, in the process, the company is improving the efficiencies and effectiveness of its team and supporting its growth as it expands its global reach. Learn more.
With expansion of laboratory services on a worldwide stage, public credibility is critical, as is regulatory compliance with regard to internal operations. Managing these factors can be challenging, particularly in the dynamically changing environment of such a highly regulated industry. Read how this company found its solution in Pilgrim Quality Solutions' automated platform, enabling it to manage its change control, CAPA and deviation activities with standardized processes and instant visibility, in real time, to quickly and proactively identify where and what action is needed to ensure smooth operations and continuous compliance. Learn more.
Life sciences mergers and acquisitions of other medical device companies led this global medical device manufacturer toward a standardized Nonconforming Event or Prevention (NCEP) and CAPA management system. Read how their implementation brought the common needs of functional groups across 20 operational locations together, creating a harmonized process with increased efficiency and productivity. Learn more.
Overall, today's biotechnology industry is maturing, and must continue to evolve as growing pressures bear down. The industry is facing significant challenges from operational factors – including increasingly stringent regulatory forces – as well as from business, clinical development, and market risks. Business fundamentals, which many biotech companies have had the luxury to ignore, are now emerging as critical elements for sustainability and survival. Discover how one biotech enterprise selected and implemented an electronic document management system, providing a sound framework to support continuous process improvements while creating a collaborative environment for the businesses to work and improve. Learn more.
As highly regulated businesses face ever more stringent regulatory scrutiny, companies need to precisely track their employees' training and certification status through standardization of their overall approach to technical staff training. With expansion of laboratory services on a worldwide stage, public credibility is critical, as is regulatory compliance with regard to internal operations. Read how this company implemented SmartSolve Training Management to ensure up-to-date accuracy and ease-of-access to laboratory employee training records. Learn more.
Today’s Life Sciences organizations are seeing a growing occurrence of adverse events, safety problems, and product recalls, driving these companies to take an integrated approach to product quality, safety, and vigilant risk management. Discover how this global medical diagnostics company is proactively precluding these occurrences by driving global product quality and customer satisfaction. Read how it selected and implemented an integrated software solution that streamlines the entire complaint collection resolution lifecycle, enabling enterprise-wide standardized complaint handling processes and the ability to manage deviations and incidents in real-time for quick resolution. Learn more.
Medical device manufacturers must meet stringent regulatory requirements to remain both in compliance and in business. This medical device manufacturer is no exception. Discover how one medical device company faced document management challenges and lacked a well-defined change control process. As the company continued to grow, they needed an EQMS system that would allow them to meet regulations to expand into the U.S. market. Learn how this organization addresses its quality and compliance concerns, initially focusing on one aspect of their quality management needs, integrated document management. Learn more.
Complicated and siloed systems leave an organization vulnerable to regulatory scrutiny, and can lead to failed audits, potential recalls, harmed reputation, loss of customer trust, and loss of profits. Conversely, by automating the business processes that impact quality and compliance, a company can successfully streamlined its overall operating environment and proactively reduce those vulnerabilities. In this case study, read how one medical device manufacturer implemented an enterprise-wide document management application that improves the accessibility and quality of critical documents, and a training application that automates this company’s employee training records and certifications. Learn how, together, these solutions are minimizing risks and maximizing savings for this manufacturer. Learn more.
Comprised of more than a dozen separate Life Sciences sites, with nearly as many disparate systems for managing customer complaints and adverse events, CAPAs, and audits, this medical device manufacturer reduced its cost of quality by 15%. Discover how they are achieving this and other benefits with their integrated EQMS solution. Learn more.
For contract manufacturers operating within a highly regulated industry, it is critical that their entire operation maintain a fully integrated quality and compliance management system to both ensure their own sustainability and to secure confidence among their customers who have entrusted them with the care of their assets. In this quality management case study, read how this globally respected company has implemented a fully integrated, pre-built software solution to satisfy its user requirements, its Lean Six Sigma standards, and U.S. and global regulatory requirements. Discover how automation with a highly visible, lean, real-time, cGMP-compliant system effectively minimizes the potential for cGMP non-compliance, while boosting customer satisfaction and the company's bottom line. Learn more.
Without a fully reliable and easily traceable process for complaint record management, regulated companies face critical risks that no enterprise can afford. In today's increasingly competitive manufacturing environment, the race is on to identify and implement a quality and complaint management system that harmonizes functions worldwide, improves efficiency and productivity, and helps maintain ongoing compliance and customer satisfaction. Discover how this manufacturing company has been able to manage customer complaints in a regulated environment, and execute effective, timely resolutions to customer issues through implementation of Pilgrim's fully-automated, closed-loop Complaint Management. Find out the resulting benefits of the enterprise-wide solution, including increased complaint handling efficiencies, increases in other key critical process efficiencies, minimized risk, and the assurance of ongoing FDA compliance. Learn more.
Blood services organizations manage volumes of critical data, both internal documents and blood product and processing information from remote collection sites. Each day, these organizations depend on compliance and quality management systems that will ensure a safe, reliable, effective, and innovative blood supply. Learn how Red Cross Flanders Blood Services has revolutionized its compliance and quality management operations with the successful implementation of a fully automated document management solution, and discover how that solution has put the regional organization at the forefront of today’s blood banking industry. Learn more.