Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to statistical process control. PLA 3.0 also provides a set of add-ons that support and supplement data analysis add-ons.
Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain a reportable value from independent assay runs and use historic assay data to develop equivalence margins.
Use Quantitative response assay documents to calculate relative potencies of Test samples compared to a Standard sample. If you provide information on the stock solutions or raw materials, you can also determine absolute potencies based on several types of calculations.
Find details on the advanced setup of Quantitative response assay documents.
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Details on documents and templates, the data editors and the Content editor of PLA 3.0.
Find details on the system requirements for the Biological Assay Package add-on and the steps to install the add-on in your environment.
Use Basic bioassay protocol documents to combine the results of multiple independent assay runs into reportable values. Organize complex methods, retest scenarios, and report several products in a single assay.
Use Combination of assay results documents to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.
Use Equivalence margin development documents to utilize data of historic assays to develop and verify test systems and use these systems to apply them in new assay development.
The Quantitative response assay document type supports a range of quantitative response or dilution assay types, that is, parallel-line potency assays, parallel-logistic potency assays, and slope-ratio potency assays.
Quantitative response assay documents use a set of concepts you should be familiar with when working with this document type.
Use response data processing to configure the processing of response data, for example, to subtract the absorbance of blank wells or to divide response values by the mean absorbance of maximum binding wells.
Use regression models and simultaneous regression to set up regression analysis for your assay elements.
Data selection schemes define which data are considered in the analysis. You can select, for example, which data points or dilution steps you want to include. The default scheme simply selects all data points.
Use Analysis of Variance (ANOVA) to determine sources of variation in statistical models. ANOVA employs several methods to estimate variance in the data. It then tests to what extent the results agree. PLA 3.0 supports two ANOVA models, that is, pure-error ANOVA and residual-error ANOVA.
Assays are based on curve similarity. Suitability tests allow you to check the validity of calculations every time they are performed. We therefore recommend you set up suitability tests for every quantitative response assay.
Run the calculation once you have completely set up the assay document. Results of the calculation are added to the assay document.
The methods and procedures provided by the Quantitative response assay document type are based on use cases and requirements from literature.
Use Test system definition documents to define a collection of suitability tests and corresponding margins for Quantitative response assays.
Find reference information on the document types of the Biological Assay Package add-on.
Use the Biological Assays Simulation Package to create simulations of quantitative response assays (QRAs) and use the Quantitative response assay document type of PLA 3.0 to store the simulated data.
Use the bioMérieux Endotoxin Detection Assay Package add-on to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by the bioMérieux company.
The Control Chart Package allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.
Use the Dichotomous Assay Package to analyze biological assays based on quantal (binary) responses by fitting probit or logit models to estimate the potency of your samples.
The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
Use the Generic Document Types Package add-on to document general information.
Use the Integration Report Package for creating reports in additional file formats that are not covered by the standard PLA 3.0 reporting functionality. These reports can be used for example for automated processing in third-party software.
The Measurement Documentation Package add-on is a universal add-on for documenting different aspects of a measurement. Its documents can be referenced by other document types, for example, Quantitative response assays.
The Microbial Assays for Antibiotics Package for PLA 3.0 is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
Use the Split Assay Package to split a Quantitative response assay with several Test and Control samples into individual assays, each with the Standard and one Test or Control sample.
Use the Toolkit for Biological Assay Package to modify the analytical settings of larger sets of Quantitative response assays or split Quantitative response assays with more than one test or control sample into individual assays.
Use data acquisition and data import add-ons to import external response values and observation data into PLA 3.0 for further processing and evaluation.
Details on the deployment and installation of licensed PLA 3.0 versions.
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
PLA 3.0 supports you in achieving compliance with regulations such as ISPE GAMP® 5 and 21 CFR Part 11. It also provides options to validate PLA 3.0 in your environment.
Download PDF guides of current and previous framework and add-on versions.
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