Success Stories

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.

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.

Applicable Industry: Contract Services, Contract Manufacturing Organizations, CMOs
Applicable solution: Document Management, Training & Certification Management, CAPA Management

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.

Applicable Industry: Manufacturing, Life Sciences
Applicable Solution: Complaint Handling, Synchronization Agent Integration, Validation

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.

Applicable Industry: Bood & Tissue
Applicable Solution: Document Management, CAPA Management

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.

Applicable Industry: Medical Device, Pharmaceutical
Applicable Solution: Complaint Handling, Regulatory Reporting, Integration to SAP, Integration to Web Portal