Abstract: A method of automated review of communications comprises: receiving, by a computer system, a document from a requestor application; extracting layout information and text from the document; extracting, based on the layout information, values of one or more predefined data items from the text of the document; producing a document validation result by analyzing the one or more data items; embedding, into the document, one or more human-readable comments reflecting the document validation result; and forwarding, to the requestor application, the document comprising the one or more human readable comments.

Abstract: Validating and maintaining respective validated status of software applications and manufacturing systems and processes is presented herein. A validation system can comprise a mapping component configured to extract, from a set of requirement specification documents, individual requirement specifications; and extract, from a set of test function documents, test steps. Further, the validation system can comprise a tracing component configured to generate a trace matrix associating the individual requirement specifications with respective test steps of the test functions or respective documents of the set of requirement specification documents. In an aspect, the validation system can enforce, via respective object linking and embedding control extensions, respective roles of authors, reviewers, and approvers of the set of requirement specification documents. In another aspect, the validation system can electronically receive and insert test results in the set of test function documents.

Abstract: Validating and maintaining respective validated status of software applications and manufacturing systems and processes is presented herein. A validation system can comprise a mapping component configured to extract, from a set of requirement specification documents, individual requirement specifications; and extract, from a set of test function documents, test steps. Further, the validation system can comprise a tracing component configured to generate a trace matrix associating the individual requirement specifications with respective test steps of the test functions or respective documents of the set of requirement specification documents. In an aspect, the validation system can enforce, via respective object linking and embedding control extensions, respective roles of authors, reviewers, and approvers of the set of requirement specification documents. In another aspect, the validation system can electronically receive and insert test results in the set of test function documents.

Abstract: The present invention relates to a software process that provides: an increase in the productivity in the validation process; tracking of the validation inventory, paperless execution of validation protocols; automation of revalidation schedule with alert features; increased validation efficiency; and ensures compliance to FDA regulations.