Medical Device Manufacturing Execution Systems
Solution

Endeavor was retained to drive and manage the Blueprinting process by which those requirements would be developed. Through facilitating comprehensive interviews and consensus-building workshops — with cross-functional stakeholder representation —, Endeavor developed key deliverables to serve as the foundation for the project’s design phase.

 

In addition to a validation level URS, Endeavor also developed a number of deliverables, including a dependencies and assumptions list, an ISA-95 analysis, and updated process maps to represent the new manufacturing process.

Benefit

The Blueprinting — both the deliverables and requirements — provided an excellent and detailed foundation for the project. The capabilities required for the design and prototype phases were clearly outlined.

 

With over 400 requirements, all of which used the MES software package-specific terminology, good structure was key to the system’s functional design. Additionally, it was necessary to allow organization by manufacturing stage and function. The basic assumptions and dependencies underscored and formalized key points to either finalize open issues, or drive open action items required by other initiatives.

Problem

A large medical device manufacturer had committed to a major MES project in conjunction with a new, proprietary manufacturing process to be deployed in a new plant. This MES design would be a using a common best practice “Manufacturing Compliance Platform”; the plan was to use the MCP for both this and future site expansions.

 

The client recognized the need to assign key stakeholders from the engineering, operations, and IT departments in order to develop a comprehensive set of user requirements. These requirements would outline the capabilities and functions they needed to find in a software vendor, which in turn would enable them to improve their process and allow for an Electronic Batch Record (EBR).

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