Automated validation processing and workflow management

A system to automate validation of equipment and/or processes for use in a pharmaceutical and/or biotechnology manufacturing facility comprising:

• a computing application, said computing application comprising:
• a user interface capable of accepting and/or displaying validation processing information,
• wherein said user interface maintaining at least one dialog box populated with selectable validation processing information,
• a validation processing engine, said validation processing engine comprising at least one processing rule operating on validation processing information to generate at least one validation protocol;
• and
• a data store, said data store cooperating with said computing application to store data representative of validation processing information and validation protocol information.

A system to automate validation of equipment and/or processes facility comprising:

• a computing application operating between at least one client computer and one server computer cooperating over a communications network,
• wherein said communications network comprises any of comprising any of:
• a fixed wire local area network, a wireless local area network, a fixed wire wide area network, a wireless wide area network, a fixed wire intranet, a wireless intranet, a fixed wire extranet, a wireless intranet, a fixed wire extranet, a wireless extranet, a fixed wire peer-to-peer network, a wireless peer-to-peer network, the wireless Internet, and the Internet,
• said computing application comprising:
• a user interface capable of accepting and/or displaying validation processing information,
• wherein said user interface maintaining at least one dialog box populated with selectable validation processing information,
• a validation processing engine, said validation processing engine comprising at least one processing rule operating on validation processing information to generate at least one validation protocol;
• and
• a data store, said data store cooperating with said computing application to store data representative of validation processing information and validation protocol information.

A system to automate validation of equipment and/or processes facility comprising:

• a computing application operating as a feature of a computer assisted design (CAD) platform, said computing application comprising:
• a user interface capable of accepting and/or displaying validation processing information,
• wherein said user interface maintaining at least one dialog box populated with selectable validation processing information,
• a validation processing engine, said validation processing engine comprising at least one processing rule operating on validation processing information to generate at least one validation protocol;
• and
• a data store, said data store cooperating with said computing application to store data representative of validation processing information and validation protocol information.

In a computing environment, a method providing automated validation and validation workflow management comprising the steps of:

• receiving data representative of equipment and/or process data requiring validation selected through a user interface;
• processing said received equipment and/or process validation data by a validation processing engine, said validation processing engine executing at least one validation processing rule;
• generating at least validation protocol based on said received equipment and/or process validation data;
• and
• generating validation workflow management work-products, said validation workflow management work-products comprising any of status information of validation testing, calendaring information for outstanding executions of validation protocols, flag information for outstanding executions of validation protocols, status information for validation projects in total, status information for portions of validation projects, account information about participating users, credential information about participating users, user rights information, and user rights information, user rights controls, scheduling information about validation projects.