# US 2014/0195446 A1 · Techniques for qualification and maintenance of scientific information system devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0195446 A1 - Document ID: US20140195446A1 - Status: Published application - Kind: A1 - Application number: 14/118,606 - Filed: 2012-06-13 - Published: 2014-07-10 - Earliest claimed: 2011-06-15 - Assignees: Waaters Technologies Corporation - Inventors: Dana Yurach; Peter Bastek; Catalin Ristache - Web page: https://patentgrep.com/patent/US20140195446A1 ## CPC - G06Q 30/018: Certifying business or products - G06F 11/3055: {Monitoring arrangements for monitoring the status of the computing system or of the computing system component, e.g. monitoring if the computing system is on, off, available, not available (error or fault processing without redundancy G06F11/0703; error detection or correction by redundancy in data representation G06F11/08; error detection or correction of the data by redundancy in operations G06F11/14; error detection or correction by redundancy in hardware G06F11/16)} - G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades - G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract Described are techniques for determining a qualification status of a device in a system. An occurrence of a trigger event for the device is determined. The trigger event is caused by an occurrence of any of a time-based event, a performance-based event, a usage-based event, and an unscheduled event. A user notification is provided to perform a first action responsive to the occurrence. The first action is an action to perform any of a maintenance activity, a repair activity, and a test for the device. The qualification status of the device is updated in accordance with said first action. Also described are techniques for more generally determining a compliance status of a device where the compliance status may be related to any one or more of qualification, verification, validation and/or calibration of the device. ## Claims ### Claim 1 A method for determining a qualification status of a device in a system comprising: determining an occurrence of a trigger event for the device, said trigger event being caused by an occurrence of any of a trend-based event, time-based event, a performance-based event, a usage-based event, and an unscheduled event; providing user notification to perform a first action responsive to said occurrence, said first action being an action to perform any of a maintenance activity, a repair activity, and a test for the device; and updating the qualification status of the device in accordance with said first action. ### Claim 2 (depends on 1) The method of claim 1, wherein said first action is a maintenance activity or a repair activity and the method includes: creating a log including information regarding the maintenance or repair activity, the log including requalification criteria used in determining whether requalification is needed responsive to performing the maintenance or repair activity, said requalification criteria including a severity associated with the maintenance or repair activity; and determining, in accordance with said requalification criteria, whether to set the qualification status of said device to unqualified. ### Claim 3 (depends on 2) The method of claim 2, wherein said determining determines to set the qualification status of the device to unqualified, and the method further comprising: updating a user interface element to indicate the device having an unqualified status. ### Claim 4 (depends on 3) The method of claim 3, wherein the maintenance activity or repair activity is linked to a qualification procedure used for performing one or more qualification tests for the device and the method further includes: performing testing using the qualification procedure; and updating the qualification status of the device in accordance with results of performing the testing using the qualification procedure. ### Claim 5 (depends on 2) The method of claim 2, further comprising: determining, in accordance with said requalification criteria, whether to disable the device from further use until one or more subsequent confirmatory actions are successfully performed. ### Claim 6 (depends on 4) The method of claim 4, wherein one or more qualification records are automatically created for one or more qualification tests performed using the qualification procedure. ### Claim 7 (depends on 6) The method of claim 6, wherein a next qualification date is automatically determined in response to successfully performing the one or more qualification tests. ### Claim 8 (depends on 2) The method of claim 2, wherein the first action is a maintenance action, and the log includes information indicating whether the maintenance action has been completed, and wherein a next maintenance date is automatically determined in response to indicating in said log that the maintenance action has been completed. ### Claim 9 (depends on 1) The method of claim 1, wherein said test is a qualification test for the device. ### Claim 10 (depends on 2) The method of claim 2, further comprising: determining, in accordance with said requalification criteria, whether to set the qualification status of the device to not qualified until one or more subsequent confirmatory actions are successfully performed. ### Claim 11 (depends on 10) The method of claim 10, wherein said one or more subsequent confirmatory actions include performing a qualification test for the device. ### Claim 12 (depends on 1) The method of claim 1, wherein the device is included in a regulated system operating in accordance with regulatory requirements. ### Claim 13 (depends on 1) The method of claim 1, wherein said device is a scientific laboratory instrument. ### Claim 14 (depends on 13) The method of claim 13, wherein said device is a scientific laboratory instrument that performs any of liquid chromatography, gas chromatography, mass spectrometry, supercritical fluid chromatography, capillary electrophoresis, and analog to digital signal conversion and/or transmission. ### Claim 15 (depends on 1) The method of claim 1, wherein said device is a computer system. ### Claim 16 (depends on 1) The method of claim 1, wherein an occurrence of a time-based event is a planned or scheduled event that depends on an amount of lapsed calendar time. ### Claim 17 (depends on 1) The method of claim 1, wherein an occurrence of a usage-based event is a planned or scheduled event that depends on an amount of actual usage of the device, component of the device and/or part of the component. ### Claim 18 (depends on 1) The method of claim 1, wherein an occurrence of a performance-based event depends on whether the device meets specified performance criteria. ### Claim 19 (depends on 1) The method of claim 1, wherein an occurrence of an unscheduled event for the device is an unscheduled repair, unscheduled update, or unscheduled upgrade. ### Claim 20 (depends on 19) The method of claim 19, wherein an observed trend over a time period regarding an amount of downtime is used in determining the occurrence of the unscheduled event to perform the unscheduled repair. ### Claim 21 (depends on 19) The method of claim 19, wherein an observed trend over a time period regarding analytical results generated by the device are used in determining the occurrence of the unscheduled event to perform the unscheduled repair. ### Claim 22 (depends on 1) The method of claim 1, wherein the first action is a maintenance activity to replace the device with a new device, new component comprising the device, or new part comprising a component of the device. ### Claim 23 A system comprising: a plurality of scientific instruments; one or more computer systems used to control and/or communicate with the plurality of scientific instruments; a computer readable medium comprising code stored thereon for: determining an occurrence of a trigger event for a device, said device being any of the plurality of scientific instruments and the one or more computer systems, said trigger event being caused by an occurrence of any of a time-based event, a performance-based event, a trend-based event, a usage-based event, and an unscheduled event; providing user notification to perform a first action responsive to said occurrence, said first action being an action to perform any of a maintenance activity, a repair activity, and a test for the device; and updating a qualification status of the device in accordance with said first action. ### Claim 24 A computer readable medium comprising code stored thereon for determining a qualification status of a device in a system, the computer readable medium comprising code stored thereon for: determining an occurrence of a trigger event for the device, said trigger event being caused by an occurrence of any of a time-based event, a performance-based event, a usage-based event, a trend-based event, and an unscheduled event; providing user notification to perform a first action responsive to said occurrence, said first action being an action to perform any of a maintenance activity, a repair activity, and a test for the device; and updating the qualification status of the device in accordance with said first action. ### Claim 25 A system comprising: a plurality of scientific instruments; one or more computer systems used to control and/or communicate with the plurality of scientific instruments; a computer readable medium comprising code stored thereon for: determining an occurrence of a trigger event for a device, said device being any of the plurality of scientific instruments and the one or more computer systems, said trigger event being caused by an occurrence of any of a time-based event, a performance-based event, a trend-based event, a usage-based event, and an unscheduled event; providing user notification to perform a first action responsive to said occurrence, said first action being an action to perform any of a maintenance activity, a repair activity, and a test for the device; and updating a compliance status of the device in accordance with said first action. ### Claim 26 (depends on 25) The system of claim 25, wherein the compliance status is determined in accordance with compliance with any one or more of a qualification requirement, a verification requirement, a validation requirement, and a calibration requirement. ### Claim 27 (depends on 25) The system of claim 25, wherein the first action is to perform a maintenance or repair activity and the compliance status is set to not compliant after performing the maintenance or repair activity until one or more subsequent confirmatory actions are successfully performed. ### Claim 28 (depends on 27) The system of claim 27, wherein the one or more subsequent confirmatory actions include performing any one or more of a qualification test, a verification test, a validation test and a calibration test for the device. ### Claim 29 (depends on 25) The system of claim 25, wherein the test for the device is any of a qualification test, a verification test, a validation test and a calibration test for the device.