Success Stories

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Success Stories
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Oct 25, 2005, 16:05

Long term, sustainable relationships with customers are at the foundation of Pilgrim’s success. Learn in the following case studies how Pilgrim Software is helping leading organization overcome business challenges.

Healthcare Services Provider:

Like all medical and healthcare-related enterprises, this particular provider has sought to take an integrated approach to product safety, quality, and vigilance risk management. This company recognized the critical importance of managing processes from a preventative perspective, versus running operations with a reactive mindset, to avoid potentially grave consequences. Those potentially devastating consequences include product recalls, patient harm, and resulting lost profits.

Discover how this healthcare services provider selected and began implementing Pilgrim Software’s integrated risk, compliance and quality systems platform, an sound framework to continuously support proactive process improvements while maintaining process and data oversight, and create a collaborative environment for the businesses to work and improve.

Laboratory Services Company:

Among the complexities of the laboratory environment, calibration and equipment management has emerged as the first line of defense to prevent nonconformance attributable to the equipment. To overcome any potential challenges to equipment management, this company chose to proactively implement a closed-loop system that would integrate the tracking and trending among all of its laboratory groups to expedite company-wide data visibility and consistently support regulatory compliance.

This success story examines how this company chose to implement an automated Equipment Management solution, replacing its previous disparate, manual processes for calibration, preventative maintenance and asset tracking, to ensure the critical precision of its laboratory testing operations.

Blood Banking Agency:

In a highly regulated environment, the ongoing challenge for blood and tissue banking organizations is to respond to ever more demanding industry regulations, while meeting their own exacting standards. While regulatory compliance is essential to staying in business, it is also imperative to sustain a culture of continuous improvement through cost reduction and risk management, and improvement in the organizations’ overall performance.

Discover how one national blood agency implemented a quality management platform that is providing it a highly automated, high-visibility, cGMP-compliant system that minimizes the potential for cGMP noncompliance, while boosting donor/customer satisfaction and its bottom line.

Life Science Enterprise:

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:

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.:

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:

Ineffective complaint handling damage 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.

Pall Corporation:

In an era of frequent mergers and acquisitions among manufacturing corporations, some enterprises fall victim to inefficiencies due to disparate systems for managing ongoing processes such as customer complaints/adverse events, corrective and preventive actions, and internal and external audits. Without a standardized platform for these critical management systems, those companies face multiple challenges to their ongoing quality and compliance objectives.

Upon recognizing the vulnerabilities of a non-harmonized quality and compliance management operation, Pall Corporate chose to implement Pilgrim Software’s ECQM platform – a single set of solutions to support the company’s global harmonization. Learn how Pall has used the Pilgrim solution to successfully reduce risk, ensure compliance with current industry regulations, increase its efficiencies and productivity, and strengthen its overall quality and customer satisfaction.

Florida Blood Services:

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.

Contract Manufacturing Organization:

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:

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:

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:

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.

Defense Industry:

This national defense manufacturer is one of the major shipbuilders for its government and a prime contractor to its defense department. Due to the high volume of suppliers and activities involved in its projects, and the ongoing need to provide status updates to its federal government, it sought a software platform to connect people, processes and documents through an integrated quality and compliance management system that would ultimately improve organizational effectiveness and agility.

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.

Red Cross Flanders Blood Services:

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.

Blood Systems, Inc.:

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.

Please check back frequently as we will post more success stories shortly!

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