Term

Definition

Application

The v-kit Pro software, Dongle application license and v-kit logbook.

Application License

The right to use the v-kit Pro application. Perpetual license.

C2V File

A file containing details of a Dongle and the licenses activated on it.

Certificate Number

Unique reference assigned to each accepted test. The certificate number is created as follows [module serial number]-[YYYYMMDD]-[protocol run ID]-[test run ID].

Data Recording Sheet

Sheet that can be printed and used to record the data generated during a test.

Dataset

A file and folder containing the standards traceability information and certificates for a specific standard set plus procedures for the tests in a given technique. Must be imported to v-kit Pro to make the documents available.

Dependencies

Certificate numbers for previously run tests that the current test has dependencies on.

Deviation

Recorded comment that describes a deviation from the normal or expected running of a test and or protocol.

Dongle

A USB device that hold the application, technique and test licenses.

Duplicate Protocol

A protocol created from a supplied protocol that can be run in Protocol Runner.

Initia Kit

A kit that contains the technique, technique license, and accessories for a given qualification. Required to get started with a specific qualification.

Protocol

Contains the tests plus default set-points and acceptance limits for a given technique.

Protocol Manager

v-kit Pro software in which user information, imports, exports and management of protocols is performed.

Protocol Report

A report detailing the tests, set points and acceptance limits defined in the protocol.

Protocol Runner

v-kit Pro software in which qualifications are run using published protocols.

Published Protocol

A duplicate protocol that can be run in the Protocol Runner.

Refill Kit

A kit that contains the dataset, standard set and V2C File for a given qualification. Required for on-going use of a specific qualification.

Report Definitions

Definition of the appearance of protocol reports, data capture sheets, test certificates and summary reports.

Standard Certificate

Traceable certificate of analysis for a standard.

Standard Expiry Date

The date at which the standard certification expires. A test using the standard cannot be run beyond this date.

Standard Set

A set of standard solutions.

Summary Report

Report that includes a summary sheet and audit trail. Can also include test certificates, standard certificates, test procedures and user files.

Supplied Protocol

A protocol supplied with v-kit Pro. A supplied protocol can be duplicated but not run in the Protocol Runner.

Technique

The protocol for a given qualification – for example GC/MS (EI) OQ.

Technique License

The right to use a specific technique. Expiration license.

Test

Procedures, calculations and evaluations for the investigation of a specific aspect of instrument or software operation that return quantitative results and PASS/FAIL status.

Test Certificate

Certificate generated for each test that includes module details, test results and overall test status

Test License

The right to perform specific v-kit Pro tests. Execution license.

Test Procedure

Document that contains to procedure for running a test plus details of the evaluation and calculation formulae used.

Updates Folder

A directory in the v-kit Pro file structure in which all files and folders to be imported must be copied.

V2C File

A file containing technique and test licenses. Must be imported to a Dongle to activate the licenses and date.