Patent ID: 9143581
Filing Date: 2015-09-22
Classification: G06Q,H04L

Abstract:
1. A computer program product comprising a tangible and a non-transitory computer readable storage medium whose contents include a program with instructions to perform a method for generating a protocol for an assay and one or more software modules for performing the method, wherein the software modules include at least one of a guideline module, a protocol module, and a report module, wherein the method comprises: storing in a database device at least one performance characteristic parameter of an assay and storing in the database device at least one standardized analytical validation protocol for each assay of a plurality of assays and assay types; receiving a performance characteristic parameter selection and an assay selection from a client device of a laboratory through a communications device using the analytical validation protocol module and wherein the performance characteristic parameter selection comprises a laboratory location and the one or more performance characteristic parameters; retrieving one or more performance characteristic parameters and a standardized analytical validation protocol from the database device based on the performance characteristic parameter selection and the assay selection; sending the client device the one or more performance characteristic parameters and one or more study variable values of the standardized analytical validation protocol through the communications device and wherein the one or more study variable values comprises an acceptance criterion; receiving from the client device one or more amendments to the one or more performance characteristic parameters and one or more study variable values of the standardized analytical validation protocol through the communications device; and generating the analytical validation protocol for the assay based on the one or more amendments.