TRUcompare

Product Complaints System
A large research-based pharmaceutical manufacturer needed to standardize quality systems across its manufacturing sites. The consolidation of facilities in the wake of several acquisitions motivated this action. Deploying a new application for tracking and managing product complaints was central to the effort. Because this system can trigger quality investigations, its potential business impact is significant. The firm needed to guarantee the accuracy of its complaints data – including legacy content migrated to the new system.

Controlled Document Submissions
A biotechnology company initiated a program to upgrade its information systems, starting with a document management and electronic regulatory submissions application. Submissions documents were first created and managed in a separate legacy system. Plans called for migrating them to the new application once in production, where they would undergo final approvals prior to agency hand-off. However, business conditions altered plans. As a result, document approvals had to be accelerated and completed in the legacy environment. This change from "in-process" to "approved" status, meant the migration would now require validation.

Product Packaging
This recognized life sciences industry leader decided to modernize its manufacturing-related applications, including re-engineering a key product packaging system. Doing so meant replacing disparate and aging applications, including those originating in other companies long since acquired by the firm. These included both U.S. domestic and non-U.S. facilities. A new, validated system would support and enforce standard methods for creating and managing packaging content – labeling for example – as well as bill-of-material (BOM) documents. To accomplish this, existing product data and content needed to be migrated into the new system, tested and verified.