Middleware architecture for validating and controlling manufacturing processes
OwnerJuan Tiradoinventor
Life of this patent
Estimating the term…
Abstract
The present invention comprises a cloud-based interface layer comprising a plurality of telegram structures, a plurality of telegrams based on the plurality of telegram structures, and a telegram processor that parses said plurality of telegrams. The interface layer acts as a middleware architecture between a plurality of systems providing standardized storage for all of them. The telegrams are used to validate and control the processes between these systems. The systems may include a manufacturing execution system, a quality management system, a learning management, and a laboratory information management system. The interface layer is designed to be prevalidated according to one or more industry standards such as the Good Manufacturing Practices (GMP).
Claims16
A system for controlling and validating the execution of tasks in a pharmaceutical environment comprising:
- a processor;
- a network interface;
- a memory comprising:
- an access control module;
- a plurality of databases,
- a remote procedure call module,
- a standardized storage, and
- a telegram interface layer comprising:
- a plurality of telegram structures,
- a plurality of telegrams based on the plurality of telegram structures,
- a telegram processor parsing the plurality of telegrams according to the plurality of telegram structures,
- a data transfer monitor module,
- a reporting module, and
- an error handler module, wherein the plurality of telegrams that triggered an error remain in the telegram interface layer until the error is cleared.
The system of claim 5, wherein the plurality of telegram structures comprises a non-conformance telegram structure, wherein a non-conformance telegram based on the non-conformance telegram structure causes a batch/lot to be placed on hold.
A prepackaged and prevalidated application management and execution system comprising:
- a manufacturing execution system;
- a quality management system;
- a laboratory information management system;
- a learning management system;
- an enterprise resource planning system;
- a reporting system;
- and
- a middleware architecture comprising:
- a plurality of telegram structures,
- a plurality of telegrams,
- a telegram processor parsing the plurality of telegrams according to the plurality of telegram structures,
- a data transfer monitor module, and
- an error handler module,
- wherein said middleware architecture provides data to said systems in standardized form.
An application management and execution method comprising the steps of:
- managing applications for the completion of a manufacturing process comprising receiving a work order and receiving a material requirement, assembling a work order bill of materials, and generating an electronic batch record;
- monitoring application users' learning information, certifying application users' training record data, and allowing access to a manufacturing execution system and a quality management system only after certifying application users' training record;
- receiving application users' quality inspection information and generating a non-conformance record only after receiving a negative quality inspection result.
Dependencies are inferred from the claim text.