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How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

About Hollister

Hollister Incorporated is an independently owned global company that develops, manufactures and markets healthcare products for ostomy, continence, and stoma care. Hollister products are available in over 90 countries. The company has seven facilities located in the United States, Ireland, Denmark and India.

The Hollister Challenge

In 1998 Hollister learned that the IBM mainframe it was using to route controlled documents electronically throughout the organization was going to be decommissioned. This set into motion a search for a replacement solution. An internal needs assessment was conducted and Hollister determined that the new solution must have the following capabilities:

  • Electronic signature support to comply with the FDA’s 21 CFR Part 11 mandate
  • Life cycle tracking of documents
  • Version control of documents
  • Ability to rapidly search stored documents
  • Role-based permissions to manage access to documents
  • Support for multiple languages
  • 24 x 7 availability to support multiple facilities around the world

After a thorough evaluation of available document management solutions, Hollister chose QUMAS DocCompliance. Since 1998 Hollister has continually upgraded to the latest version of QUMAS DocCompliance and now uses version 4.4 of the product.

Over 700 people throughout seven facilities use QUMAS DocCompliance to manage all of Hollister’s quality documents, which include manufacturing specifications and instructions, as well as regulatory policy and procedures.

“On a global basis the Quality, Regulatory Affairs, R&D, Biocompatibility, Sterilization, and Technical Services departments all use the QUMAS solution,” stated Dawn Porter, Compliance Process Lead at Hollister. “It is now starting to also be used by the Global Engineering, Global Packaging, and IT departments.”

In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs.

Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration.

Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

After assessing several different business process management solutions, Hollister selected QUMAS ProcessCompliance.

“The fact that the products can be tied together to provide a linkage between documents and processes was a big factor in selecting ProcessCompliance,” said Dawn Porter, Compliance Process Lead at Hollister. “Also both products have the same look and feel so end user training was minimized.”

In 2011 Hollister rolled out QUMAS ComplianceUnity, a comprehensive business intelligence solution, and MyQUMAS, a unified interface for accessing all document, process, training, and reporting activities.

The QUMAS Solution

QUMAS products provide Hollister with the following key features and benefits:

Hollister has recently started to allow contract manufacturers to access the QUMAS solution to download the latest technical specifications and drawings in real time. Prior to having access to the QUMAS solution, contract manufactures had to wait for paper documents to arrive by a courier service.

“QUMAS products have helped Hollister be a more nimble company,” said Dawn Porter, Compliance Process Lead at Hollister. “We now have much better visibility of compliance activities across the entire company and can see how a problem in one facility could potentially impact additional facilities, and then take the required steps to prevent the problem from occurring globally.”

QUMAS is the leader in Enterprise Compliance Management Solutions with more than 260 global customer deployments and 20 years’ experience within the Life Sciences sector. QUMAS provides a closed-loop Compliance Platform that enables you to integrate the common elements of compliance, including content, processes, people and systems, across your organization. QUMAS Solutions for document, quality and incident management, submission management and regulatory approvals enable you to accelerate your time to market, decrease compliance risks, improve operational efficiencies and reduce overall quality costs. QUMAS is a Gold Microsoft Partner, and provides the QUMAS Compliance Platform on SharePoint 2010, Documentum, Oracle or SQL.