Techniques for use with test qualification protocols

Patent metadata

Field	Value
Publication number	US-9599491-B2
Application number	US-201214118608-A
Country	US
Kind code	B2
Filing date	Jun 13, 2012
Priority date	Jun 15, 2011
Publication date	Mar 21, 2017
Grant date	Mar 21, 2017

Abstract

Described are techniques for performing qualification protocol testing. A qualification entity category is selected indicating a category of an entity for which a qualification test protocol is generated. One or more qualification tests are selected and included in the qualification test protocol. Test information is specified for the one or more qualification tests. The test information includes first information identifying one or more code modules executed to perform said one or more qualification tests, second information identifying test inputs to said one or more code modules, and third information specifying how to evaluate tests results from executing each of said one or more qualification tests. A qualification protocol structure including said test information is generated.

First claim

What is claimed is:

1. A method for performing qualification protocol testing comprising:
performing first processing to create a qualification protocol structure for a qualification test protocol used to qualify any of software and an instrument system, said first processing including:
selecting, using a user interface, a qualification entity category indicating a category of an entity for which the qualification test protocol is being created, wherein the qualification entity category is any of software and an instrument system;
selecting, using the user interface, one or more qualification tests included in the qualification test protocol;
specifying, using the user interface, test information for said one or more qualification tests, said test information including first information identifying one or more code modules executed to perform said one or more qualification tests, second information identifying test inputs to said one or more code modules, and third information specifying how to evaluate tests results from executing each of said one or more qualification tests;
generating the qualification protocol structure including said test information; and
storing the qualification protocol structure in a database; and

performing second processing to qualify any of software and an instrument system by using the qualification protocol structure to execute the qualification test protocol, said second processing including:
receiving the qualification protocol structure from the database; and
executing a first code module that receives and interprets the qualification protocol structure as a runtime input to drive execution of the one or more qualification tests identified in the qualification protocol structure, said first code module transferring runtime control to the one or more code modules identified in the qualification structure and then, after completing execution of the one or more code modules, returning runtime control to the first code module.

2. The method of claim 1 , wherein executing said qualification test protocol includes executing the one or more qualification tests, and wherein said second processing includes generating test results in accordance with executing said one or more qualification tests.

3. The method of claim 2 , wherein executing said one or more code modules identified in said first information uses said second information as inputs when executing said one or more code modules.

4. The method of claim 3 , further comprising evaluating said test results, said evaluating using said third information to determine a testing status of pass or fail for each of said one or more qualification tests.

5. The method of claim 2 , wherein the qualification entity category identifies said instrument system.

6. The method of claim 5 , wherein said instrument system comprises a plurality of modules and the qualification protocol structure includes fourth information describing a configuration of said instrument system including said plurality of modules.

7. The method of claim 5 , wherein said instrument system is a scientific laboratory instrument system that performs any of liquid chromatography, gas chromatography, mass spectrometry, supercritical fluid chromatography, capillary electrophoresis, and analog to digital signal conversion and/or transmission.

8. The method of claim 2 , wherein said test information identifies one or more tests which are mandatory and one or more tests which are not mandatory and wherein the method includes deselecting at least one test that is not mandatory causing said second processing to not execute processing for said at least one deselected test.

9. The method of claim 2 , wherein the qualification entity category identifies software installed on a computer system and the qualification test protocol includes one or more qualification tests for qualifying said software.

10. The method of claim 1 , wherein said test information includes information identifying code to generate a report regarding evaluation of test results.

11. The method of claim 1 , wherein said qualification protocol structure is bundled with any of a new software component and an updated software component, said qualification protocol structure used to perform qualification testing for any of said new software component and said and updated software component.

12. The method of claim 11 wherein said new or said updated software component is a driver used for communicating to an instrument system to operate said instrument system.

13. The method of claim 1 , wherein the qualification protocol structure is approved by electronically or digitally signing the qualification protocol structure.

14. The method of claim 13 , wherein the qualification protocol structure is exported from a first database on a first computer system and imported into a second database on a second computer system.

15. The method of claim 14 , wherein the qualification protocol structure is encrypted producing an encrypted structure, and the method further includes:
digitally signing the encrypted structure; and
processing the digitally signed encrypted structure at the second computer system, said processing including decrypting the digitally signed encrypted structure thereby generating the qualification protocol structure and importing the qualification protocol structure into a second database on the second computer system.

16. A computer readable medium comprising code stored thereon that, when executed, performs a method of qualification protocol testing comprising:
performing first processing to create a qualification protocol structure for a qualification test protocol used to qualify any of software and an instrument system, said first processing including:
selecting, using a user interface, a qualification entity category indicating a category of an entity for which the qualification test protocol is being created, wherein the qualification entity category is any of software and an instrument system;
selecting, using the user interface, one or more qualification tests included in the qualification test protocol;
specifying, using the user interface, test information for said one or more qualification tests, said test information including first information identifying one or more code modules executed to perform said one or more qualification tests, second information identifying test inputs to said one or more code modules, and third information specifying how to evaluate tests results from executing each of said one or more qualification tests;
generating the qualification protocol structure including said test information; and
storing the qualification protocol structure in a database; and

performing second processing to qualify any of software and an instrument system by using the qualification protocol structure to execute the qualification test protocol, said second processing including:
receiving the qualification protocol structure from the database; and
executing a first code module that receives and interprets the qualification protocol structure as a runtime input to drive execution of the one or more qualification tests identified in the qualification protocol structure, said first code module transferring runtime control to the one or more code modules identified in the qualification structure and then, after completing execution of the one or more code modules, returning runtime control to the first code module.

17. A system comprising:
a plurality of scientific instruments;
one or more computer systems used to control and/or communicate wi

Assignees

• Yurach Dana
• Earle Richard
• Ristache Catalin
• Waters Technologies Corp

Inventors

• Yurach Dana
• Earle Richard
• Ristache Catalin

Classifications

• G06F19/366

  Physics · mapped topic

• G01D18/00 Primary

  Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00 · CPC title

• G06F19/3412

  Physics · mapped topic

• G01N30/00

  Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography {or field flow fractionation} (G01N3/00, G01N5/00, G01N7/00, G01N9/00, G01N11/00, G01N13/00, G01N15/00, G01N17/00, G01N19/00, G01N21/00, G01N22/00, G01N23/00, G01N24/00, G01N25/00, G01N27/00, G01N29/00 take precedence) · CPC title

• H01J49/0009

  Calibration of the apparatus · CPC title