Two companies apply Pilgrim Software solutions

Response Biomedical (Vancouver, BC) and United Drug Plc. (Dublin, Ireland) are implementing software from Pilgrim Software Inc. (Tampa, FL). Response Biomedical, which produces rapid on-site diagnostic tests, has gone live with Pilgrim’s solution for complaints management to help expedite complaint handling while ensuring ongoing regulatory compliance. In addition, United Drug, which provides services to healthcare manufacturers and pharmaceutical retailers, will implement Pilgrim’s SmartSolve solution to standardize its quality and compliance operations.
Pilgrim’s Complaints Management solution provides Response Biomedical with a single source data center for tracking and managing all complaints within its facilities.

The software enables rapid complaint resolution through its e-mail notifications, and tracking and escalation capabilities; improves the management of customer communication; and ensures regulatory and industry compliance. Response chose to automate its complaints processing and eliminate manual systems allowing for easier tracking and trending analyses. The company turned to Pilgrim’s On Demand solution to help reduce the time required of its limited in-house IT staff to conduct a full implementation, including validation to comply with 21 CFR Part 11 requirements.

“We saw Pilgrim’s SAS 70-certified hosted model as the right solution for our needs,” says Marcia Zucker, Ph.D., director of clinical support, Response Biomedical. “We recently moved into a new facility, and have limited service space for servers, so choosing to implement Pilgrim’s solution on demand frees up both hardware requirements and allows our IT team more time to address other key projects.”

Pilgrim’s Complaints Management solution will enable Response to more efficiently manage customer complaints and document responses to incidents. As a result of its inherent scalability, the solution also can be expanded should Response add users, and it can be easily integrated with other automated quality and compliance management solutions. Even with expansion and integration, the On Demand model helps keep the company’s IT costs to a minimum, allowing it to increase its overall revenues.

“Our Complaints Management solution is the right software for life sciences companies like Response Biomedical because it takes the worry out of their complaint handling and overall quality assurance efforts, and enables them to redirect their resources toward other challenges facing their industry,” says Prashanth Rajendran, chief operating officer, Pilgrim. “Implementing it on-demand further expedites the ROI of the solution.”
With multiple operational units throughout Ireland, the United Kingdom, Europe, and the United States, United Drug needed an integrated Quality Management System that would enable the enterprise to manage, streamline and optimize quality and operational processes across its multiple divisions. Previously, those divisions were using a number of disparate quality management systems and processes. As a result, the data provided to United Drug’s corporate management was not presented in a standardized format, and therefore could not easily be analyzed, which potentially delayed strategic business decision-making.

Pilgrim Software’s automated solutions for documentation, CAPA and complaints handling, and audit management provide United Drug powerful and flexible solutions for managing risk, minimizing errors and ensuring enterprise-wide compliance. The company initially will implement Pilgrim’s CAPA management solution across the UK, Ireland and the United States divisions.

“In an effort to support our quality management initiatives, our objective with automation is to enhance insight into the data we collect and achieve better visibility into our current internal processes and documentation, and introduce improved reporting/trending capabilities,” says Gwyne Morely, director of quality assurance, United Drug. “Pilgrim offers us these capabilities and more, and we look forward to leveraging its flexibilities and global capabilities to help with our process improvements while maintaining process and data oversight, to create a collaborative environment for our businesses to work and improve.”

With the robust flexibility and scalability tools built into the core solutions, Pilgrim’s software will easily integrate not only additional processes, but also provide a framework for continuous improvement under one quality system platform.

“Pilgrim helps enterprises like United Drug to improve operational efficiencies while reducing risk and enhance compliance,” Rajendran says. “United Drug was seeking a solution that will automate the QA and Compliance processes and information flow throughout the entire organization. This is exactly what SmartSolve does. We look forward to being a strategic business partner in providing a sound framework for meeting United Drug’s critical compliance and quality management needs.”