Biopharmaceuticals Company

Business Challenge

The magic pill for PLM programs is a “single version of truth” for all product information. However, in this effort to unify data, packaging components—like labels, artwork/mechanicals, containers, pallets and more—are often left on the outside looking in, with data managed in obsolete or nonintegrated systems. The trickle-down impact to manufacturing surfaces in production inefficiency, suboptimal procurement, and increased compliance risk. For this pharmaceutical company running on an out-of-date and unsupported packaging specifications system, the concern of these potential impacts was legitimate, and the company was exposed to process inefficiencies and product safety risks, including:

• Inefficient workflow processes for packaging and labeling approvals
• Extensive IT support required for creation and modification of reports and labels
• Inconsistent and decentralized global documents
• Unreliable compliance data for communicating with customers and the supply chain

The Solution

Linx-AS designed, configured, and implemented a standardized packaging management system using the power of the SAP Specification Database. The solution centralized over thirty-seven different specification types—from primary specs (bottles and syringes) to secondary specs (boxes and packing) to artwork specs.

A sophisticated workflow system streamlined PLM processes across divisions (marketing, planning, procurement, compliance, packaging, and manufacturing) for the creation, review, and approval of packaging specifications. The workflow design also allowed for flexible ad hoc routing as well as a detailed audit log to ensure proper processing and compliance.

Vital packaging documents were stored centrally on SAP Document Management System (SAP DMS) and shared throughout the enterprise and supply chain via SAP collaboration tools.