Systems and methods for providing automatic batch validation of process data

A digital process data recorder/controller for validating process data associated with a manufacturing process, the process data recorder/controller being responsible for recording process data, the process data recorder/controller comprising:

• communication device or interface;
• memory for storing data;
• and
• at least one processor configured to:
• receive in real-time process data, including one or more process values, for a batch process associated with the manufacturing process at a digital process data recorder/controller responsible for acquiring the process data and recording the process data in a digital historical process data record, the one or more process values including one or more operating parameters, and the one or more operating parameters include a temperature, a pressure, and combinations thereof;
• perform a batch validation process on the digital process data recorder/controller, the batch validation process analyzing in real-time the one or more process values to validate the one or more process values of the batch process based on at least a batch validation criteria;
• transmit, via the communication device or interface, validation information including a batch validation state and a validation result for presentation on a device to a user, and/or record on the process data record in the memory the validation information including at least the batch validation state and the validation result, wherein the validation result indicates whether the batch process is conformant or non-conformant upon completion of the batch process;
• the batch process comprises a plurality of phases, the batch validation criteria including a sequence of phase validation criteria for each of the plurality of phases, the batch validation process being configured to analyze in real-time the one or more process values in each phase based on a respective phase validation criteria to validate the batch process;
• and
• selectively perform a corrective action based on the validation information, wherein the corrective action includes at least one of terminating, restarting, and pausing the batch process.

A tangible computer medium storing computer executable code, which when executed by one or more processors, is configured to implement a method of validating process data associated with a manufacturing process, the method comprising:

• receiving in real-time process data, including one or more process values, for a batch process associated with a manufacturing process at a digital process data recorder/controller responsible for acquiring the process data and recording the process data in a digital historical process data record, the one or more process values including one or more operating parameters and the one or more operating parameters include a temperature, a pressure, and combinations thereof;
• performing a batch validation process on the digital process data recorder/controller, the batch validation process analyzing in real-time the one or more process values to validate one or more process values of the batch process based on at least a batch validation criteria, the batch validation criteria including a tolerance including an upper bound and a lower bound for the one or more operating parameters, the batch validation process determining a batch validation state and a validation result for the batch process, the batch validation state indicating that the one or more process values are conformant or non-conformant at a point in time;
• controlling transmission from the digital process data recorder/controller of validation information including the batch validation state and the validation result for presentation on a device to a user, and/or recording at least on the digital process data recorder/controller the validation information including at least the batch validation state and the validation result, wherein the validation result indicates whether the batch process is conformant or non-conformant upon completion of the batch process;
• and
• selectively performing a corrective action based on the validation information, wherein the corrective action includes at least one of terminating, restarting, and pausing the batch process.