New!  Managing Growth with an Integrated Quality System in the Cloud

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 risk management, quality and compliance to help it to unify its processes across its global network, and in the process, is improving the efficiencies and effectiveness of its team and supporting its growth as it expands its global reach.

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 Software’s 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.

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 that today provides it a sound framework to continuously support process improvements while maintaining process and data oversight, and create a collaborative environment for the businesses to work and improve.

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 vigilance 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 to quickly identify resolution strategies and take fast action to resolve problems.

Life Science Enterprise (330.18 kB)

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.

Combination Products Pharmaceutical Company (329.25 kB)

Without a fully reliable and easily traceable process for complaints record management, regulated companies face critical risks that no enterprise can afford. When expanding product manufacturing and distribution on a worldwide stage, accurate and efficient adverse events management became increasingly critical. Find out how this company implemented Pilgrim Software’s Adverse Event & Complaint Recording, and its Analytics solution, to raise the bar with its response processes. Read about the solutions that replaced the previous disparate, manual systems for domestic and international customer complaint handling, and how Pilgrim’s integrated platform is effectively removing risk, improving efficiencies, and enabling improved process automation and reporting.

Nucletron B.V. (271.04 kB)

Manual document management systems are cumbersome and inefficient, and document searches prove difficult, leading to overdue situations, delayed escalations, and lack of timely communication with employees; whereas an automated, streamlined document management process will generate substantial benefits in terms of improved process efficiency and improved process results. Learn how Nucletron B.V., a European-based medical device manufacturer, in automating its business processes, has successfully streamlined its overall operating environment, leading to a more effective integration of products, software and services.

Cardinal Health (260.04 kB)

Ineffective complaint handling damages a company’s brand reputation, its products' position in the market, and its ability to market and profitably sell those products. Growing companies, especially those operating on a global stage, are particularly vulnerable if not sufficiently prepared to address customer concerns. In this case study, discover how worldwide medical and pharmaceutical products manufacturer Cardinal Health has streamlined its entire complaint resolution lifecycle – from complaint capture to investigation regulatory reporting, resolution, and customer communications, with one integrated, web-based software solution.

Contract Manufacturing Organization (350.17 kB)

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 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.

Osmetech Molecular Diagnostics (100.04 kB)

Emergent companies in the highly regulated Life Science industry require robust solutions with the capability of transforming quality and compliance processes into competitive advantage.  Find out how Osmetech Molecular Diagnostics evaluated its existing process management needs and adopted the best solution to support its continued emergence in the growing medical device and diagnostics marketplace.

Millipore Corporation (88.17 kB)

Regulated companies that operate under fragmented quality and compliance management systems, including disparate programs for audit, CAPA and customer complaints management, cannot afford to remain complacent about resulting deficiencies in the current era of increasing regulatory pressure.  Discover how Millipore Corporation successfully implemented a world-class ECQM system in just thirteen months, spanning its enterprise, with integrated and streamlined key processes that have increased efficiency and worker productivity, improved compliance capability, and reduced regulatory risks.  This study outlines the challenges Millipore was previously facing, the solution for tackling those challenges, and the resulting business benefits that today are keeping the company at the forefront of its industry.

Manufacturing/Medical Device (305.51 kB)

Without a fully reliable and easily traceable process for complaints 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/complaints management system that relates 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 SmartComplaints solution. Find out the resulting benefits of the enterprise-wide system, including increased complaints handling efficiencies, increases in other key critical process efficiencies, minimized risk, and the assurance of ongoing FDA compliance.

Blood Systems, Inc. (138.63 kB)

Fully integrated Quality and Compliance Management System Provides Leading Blood Services Organization with a Framework for Excellence.  Find out how Blood Services Inc. cut time to generate reports from months to minutes and produce 'right first-time quality' with a single integrated solution.

Florida Blood Services (328.21 kB)

Mergers and consolidations are a blood services trend. In challenging economic times, they allow organizations to streamline operations and cut costs – eventually. At the outset, however, the high cost of integrating infrastructure, maintaining compliance, and managing disparate donation centers can drain capital and human resources.  Learn how Florida Blood Services adopted an effective and fully integrated, enterprise-wide compliance and quality management system, enabling it to blend its operations into one streamlined mechanism to drive compliance, quality and customer satisfaction.

Red Cross Flanders Blood Services (709.17 kB)

Blood services organizations manage volumes of critical data, both internal documents and blood product/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.

Defense Industry (311.8 kB)

This defense manufacturer was seeking a Web-based document management solution that would support the creation, management and sharing of critical documents, such as Engineering documents and SOPs, throughout the entire operation, as well as a closed-loop CAPA management solution that allows users in any department to proactively initiate an investigation to quickly resolve an issue and prevent recurrence.  Read how, by automating document and CAPA management processes and increasing the reporting capabilities of its worldwide project team, it has successfully centralized and streamlined its overall operating environment, leading to a more effective integration of its global operations.

Businesses today are getting more complex and major global enterprises have no other choice than to improve their organization and compliance to world standards in order to maintain their position as a supplier of choice.  In response, this chemical company is continually striving to strengthen its quality through strategic commitment across the entire global enterprise.  Read how the implementation of Pilgrim Software’s quality management system is today providing a highly automated, high-visibility, lean, real-time system that effectively minimizes this company’s potential for noncompliance, while boosting efficiencies, customer satisfaction and its bottom line.