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.
Applicable Industry: Pharmaceutical, Medical Device
Applicable Solution: Complaint Management, Regulatory Reporting, MedDRA Dictionary Adapter, Reporting and Analytics
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.
Applicable Industry: Life Sciences, Healthcare
Applicable Solution: Document Management, CAPA Management, Change Management, Complaint Handling, Audit Management
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.
Applicable Industry: Clinical Laboratory
Applicable Solution: Equipment Calibration
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.
Applicable Industry: Blood & Tissue
Applicable Solution: Document Management, Training & Certification Management, CAPA Management, Audit Management
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.
Applicable Industry: Blood & Tissue
Applicable Solution: Audit Management, Nonconformance Management, CAPA Management, Document Management, Change Management, Training & Certification