The idea of sharing is currently everywhere in the private space: countless new (and old) business models are conquering the market: car sharing, food sharing, flat sharing - everything is there. But what does it look like in the professional context? Software sharing? Idea sharing? Or maybe even content sharing? How can the idea of sharing be implemented, for example, in the regulated environment of the pharmaceutical or medical industry?
For example, Good Manufacturing Practice and the FDA require GxP-regulated companies to validate e.g. the computer systems they use. Thus also a Manufacturing Execution System (MES) like the Opcenter Execution Medical Device from Siemens. The GxP-regulated companies must therefore validate a new tool along the GAMP 5 guideline before introducing it. The validation includes writing the User Requirements Specifications (URS), deriving the Functional Specification (FS) as well as the Configurational Specification (CS) and the associated testing of these functionalities.
As you can imagine, this means a lot of extra work. Opcenter Execution Medical Device has therefore documented standard functionalities in their tool of choice - Polarion - and created a standard package from it. This standard package is made available to customers for the validation of the MES system - according to the motto: Sharing is caring.
Be curious not only about what is behind this sharing package, but also how you can use this approach for other tools/systems/equipment to be validated.
You will learn
Structured approach to validation creates transparency
Reuse strengthens quality
Time saving by processing the current information for those involved
Meet the speaker
Product Account Development Specialist for ALM in Med-Tech & Pharma