This evidence helps to ensure confidence that products being produced by the manufacturer are both safe and efficacious for public consumption.Amazon.com: Factor Analysis: Scale Development & Validation: Exploratory and Confirmatory Factor Analysis with SPSS 23.0 and SPSS AMOS 23.0: 9786202197045.Entering Data in SPSS Statistics The 'one person, one row' Rule. Laboratories operating in regulated environments are required to conduct instrument validation tests in order to produce documented evidence that instruments are fit for intended use and operate in a controlled manner to produce accurate results. These instruments run the gamut from simple apparatus to complex systems that combine a metrological function with software control. Analytical instruments provide important scientific data about manufactured products that serves to ensure that they meet specifications. Strictly speaking, a scale or subscale is a group of items selected to measure a particular construct but there is a lot of confusion in the usage of the term Likert scale. Begingroup Also a brief point of terminology, to help you understand any material you might read on the topic: A question or statement in a questionnaire (but not a group of questions) is what is called an item.
Tips for.Because of their potential for impacting product quality, laboratory instruments are key targets of FDA inspections. Questionnaire Using SPSS Step By Step Validity questionnaire. A case is the 'object' which you are measuring in someway.containing questionnaire validation of validating instruments could contribute to. The principle behind entering data in almost all cases in SPSS Statistics is to enter each unique case on a new row.
inductively coupled plasma-emission spectrometersWhile categorizing laboratory instruments into three categories provide a useful starting point when discerning what kind of qualification protocol is necessary for an instrument, it should be noted that the same type of instrument can fit into one or more categories depending on its intended use.In addition, due to the wide diversity of laboratory instruments in use, and the different ways these systems are used, a single prescriptive approach for instrument qualification would be neither practical nor cost-effective. Group C instruments will require proper calibration protocols, often including software validation, to ensure their proper functioning.Examples of instruments in this group include the following: The extent of activities necessary may depend on the criticality of the instrument for ensuring product quality.Group C: Computerized laboratory systems that typically consist of an analytical instrument that is controlled by a separate workstation running instrument control and data acquisition, and processing software. Often, Group B instruments will only require calibration, maintenance or performance checks to verify proper function. Examples of equipment in this group are muffle furnaces, ovens, refrigerator-freezers, water baths, pumps, and dilutors.
Thus, no qualification of the firmware is needed – when the instrument hardware is qualified at the user-site, the firmware is also essentially qualified. In most cases, the firmware cannot be altered by the user and is therefore considered a component of the instrument itself. The software part of the more complex analytical instruments can be divided into different groups:Firmware: Many instruments contain integrated chips with low-level software (firmware) that is necessary for proper instrument functionality. Software Validation with Instrument QualificationIt is becoming more and more difficult to separate the hardware and software parts of many modern analytical instruments. Generally speaking, the more critical an instrument is to product quality, and the more complex the instrument, the more work will be required to ensure adequate qualification status.
non-configurable software that can’t be modified to change the business process Since the software is needed for data acquisition and calculations, both the hardware and software are essential for obtaining accurate analytical results from the instrument.The software in these more complex instruments can be classified into three different types: User-defined programs need to be documented in change control and access to them should ideally be restricted to authorized personnel.Instrument Control, Data Acquisition, and Processing Software: More complex analytical instruments are typically controlled by a separate workstation computer running instrument control and data acquisition, and processing software. Any firmware calculations need to be verified by the user, and firmware programs need to be defined and verified by the user to demonstrate that they are fit for intended purpose. In this case, the firmware version should be recorded as part of Installation Qualification (see below) activities, and any firmware updates should be tracked through change control of the instrument.Some instruments come with more sophisticated firmware that is capable of fixed calculations on the acquired data, or even firmware that enables users to define programs for the instrument’s operation.
The user requirements must define every requirement relating to safety, identity, strength, purity, and quality of the product.The next steps in qualifying an instrument and establishing fitness for purpose proceed as follows:Design Qualification (DQ): The DQ seeks to demonstrate that the selected instrument has all the capabilities necessary to satisfy the requirements. The first step involves the creation of user requirements, which effectively specify the operational and functional requirements that the instrument is expected to fulfill. Qualification Process and Required DocumentationAIQ is not an isolated event, but instead consists of interconnected activities that occur over the lifetime of the instrument. As a result, the software validation and analytical instrument qualification (AIQ) can be integrated into a single activity to avoid duplication. configurable software with customization options (i.e., custom software or macros to automate the business process)In these cases, the software is needed to qualify the instrument and instrument operation is necessary when validating the software.
If the use of the instrument changes, or if it undergoes a software upgrade, it is important for the user to review and update DQ documentation.Installation Qualification (IQ): The IQ documents the activities necessary to establish that the instrument was received as designed and specified, is correctly installed in the right environment, and that this environment is suitable for the proper use of the instrument. However, it may be wise for the user to verify that the supplier has adopted a robust quality system that serves to ensure the vendor specifications are reliable. Verification that instrument specifications meet the desired requirements may be sufficient for commercial off the shelf (COTS) instruments. This information will help ensure that the instrument can be successfully implemented for the intended purpose.
Software Functions – When applicable, OQ testing should include critical elements of the configured software to show the instrument works as intended. If the user trusts the manufacturer supplied specifications for these parameters, these tests may be waived. These parameters will not change over the life of the instrument and therefore do not need to be retested. Fixed Parameters – These tests measure the instrument’s non-changing parameters (e.g., length, height, weight, voltage inputs, acceptable pressures, loads). OQ activities should simulate actual testing conditions, including worst-case scenarios, and be repeated enough times to assure reliable testing results.Testing activities in the OQ phase should include the following parameters: OQ demonstrates fitness for selected use and should reflect the user requirements.
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