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Data analysis
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.
Control Chart Package
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.
Set up Control chart documents
Control chart documents allow for a comprehensive analysis of your assays and support you in setting up automated, semi-automated, and manual monitoring of your assays. They can aggregate data from different document types, such as Quantitative response assay documents or Dose-response analysis documents.

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Data analysis
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.
- Biological Assay Package
  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.
- Biological Assays Simulation Package
  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.
- bioMérieux Endotoxin Detection Assay Package
  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.
- Control Chart Package
  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.
  - Installation
    Find details on the system requirements for the Control Chart Package add-on and the steps to install the add-on in your environment.
  - Control charts
    Use Control chart documents to set up your statistical process control mechanisms.
  - Use cases
    Find details on how you can use the Control Chart Package in your daily business.
  - Set up Control chart documents
    Control chart documents allow for a comprehensive analysis of your assays and support you in setting up automated, semi-automated, and manual monitoring of your assays. They can aggregate data from different document types, such as Quantitative response assay documents or Dose-response analysis documents.
    - Create a Control chart document
      Create a Control chart document as the target document for monitoring a set of assay attributes.
    - Add references to source documents
      In your target document, add references to the source documents from which you want to aggregate data.
    - Configure the data table
      Set up data aggregation filters in your target document to decide which referenced documents to use as source documents and from which sections in your source documents to aggregate data. Use dataset columns to decide which parameters to aggregate and how to plot them.
    - Define the charts
      Define the charts you want to use to visualize the aggregated parameters. You can define several charts within a single Control chart document. Each chart uses the same observation data but you can configure each one to highlight different aspects.
  - Reference information
    The reference provides reference information on the document types of the Control Chart Package.
- Dichotomous Assay Package
  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.
- Dose-Response Analysis Package
  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.
- Generic Document Types Package
  Use the Generic Document Types Package add-on to document general information.
- Integration Report Package
  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.
- Measurement Documentation Package
  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.
- Microbial Assays for Antibiotics Package
  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).
- Split Assay Package
  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.
- Toolkit for Biological Assay Package
  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.
Data import
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.
Installation
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Administration
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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.
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Glossary
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Set up Control chart documents

Control chart documents allow for a comprehensive analysis of your assays and support you in setting up automated, semi-automated, and manual monitoring of your assays. They can aggregate data from different document types, such as Quantitative response assay documents or Dose-response analysis documents.

Before you begin

Control chart documents use the data aggregation concept of PLA 3.0. We recommend becoming familiar with this concept before setting up documents. For details, see the Data aggregation topic.

About this task

This example is based on the 01 Plotting Relative Potency and Confidence Intervals sample document. The Control chart document you create shows relative potency data series plots with their upper and lower confidence limits as intervals.

The document has two charts. The first chart shows the intervals as bars, the second chart shows them as areas. You add a sidechart that draws horizontal lines at the mean and the 1 standard deviation interval borders.

Procedure

Setting up the Control chart document comprises the following steps:

Figure 1. Steps to set up a Control chart document for assay monitoring

You can complete the steps in any order. However, we recommend the order indicated in the figure. Start by creating a Control chart document as your target document. Add document references, followed by the configuration of the data table. Once the data aggregation filters work as intended, complete the setup by defining the charts.