If there is one paper we can trace the origins of the development of Spike Prototype to, its this one;
‘Bringing new products to market faster’ by Adam Fermier, Paul McKenzie, Terry Murphy, Leif Poulsen and Gene Schaefer.
You are going to have to be a member of ISPE in order to read it, but its worth it. The article focused on data mining and pulling data from existing control and MES systems and then presenting that data in an S88 / S95 aligned format in order to expedite the recipe development process. Quoting from the paper;
The overall business objective is to bring new products faster and more efficiently to the market. To do this, the complete development process from discovery to commercial manufacture of new drugs must be standardized and based on common recipe data models and tools.
The article outlined how critical process parameters, critical material attributes and critical quality attributes together with a procedural model formed the basis of regulatory filings. It was this combination of both processes as well as quality testing methods/data all located within the same repository that would provide regulatory bodies with clear definitions and processes for the control strategy.
Other functions of the recipe data warehouse were outlined such as modeling /specification. It was noted however, that the recipe data warehouse would have to be validated if it were to transfer recipes to other live / validated systems.
Spike prototype is not validated software, so it cannot be used to store live recipes. Neither does it have interfaces to live plant systems so it is not a data mining repository (it resides on SQL server but that is where the similarities end). Version 1 is not ‘product lifecycle management’ software, but is prototyping software released and available now; just check out the videos. We are not one of those companies that talk a good PLM game, then develop the product on your tab. Even though we are natively based on the key enabling technology for this data mining warehouse concept (OPCUA), that is not the intent for Spike version 1. Spike Prototype can however act as a catalyst for standardised S88/S95-style communication throughout the enterprise, when it comes to product lifecycle management. Material properties, Quality test specification, recipe parameters etc are all easily added in a matter of seconds to a central SQL server based repository, and then made accessible to all authorised personnel via a webserver.
The purpose of Spike Prototype is simply to give process, quality, MES and automation engineers as well as tech transfer teams the ability to rapidly wireframe out their vision and communicate that throughout the enterprise, with minimum hassle. After all, that is what a design ‘spike’ is.