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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.
Control charts
Use Control chart documents to set up your statistical process control mechanisms.
Document status
Configure severity levels for your rules and use the resulting document status to quickly ascertain the criticality of a rule violation.

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Explore PLA 3.0, its key features and ongoing enhancements. Learn how it fits into your environment, and how to log in and register.
User interface
PLA 3.0 supports you in your daily work by providing a set of graphical and textual user interface elements. Learn about the different elements and how to use them efficiently.
Key concepts
Details on documents and templates, the data editors and the Content editor of PLA 3.0.
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.
    - Chart elements
      Use chart elements to set up charts according to your requirements.
    - Subcharts
      By default, all observations of a data table column are plotted in the same chart. You can split one chart into several subcharts or plot only a subset of data in subcharts.
    - Events
      Use events to set a marker on the x-axis of your chart. Events can be anything you want to visualize in a chart, such as the replacement of a reagent, an adjustment to an SOP, or the recalibration of an instrument.
    - Rule sets
      Use rule sets as a unified control system to apply the same visualization options to multiple rules, adjust periods of validity using events, and monitored data series for multiple rules based on control limits and control rules.
    - Document status
      Configure severity levels for your rules and use the resulting document status to quickly ascertain the criticality of a rule violation.
    - Color by secondary characteristic
      Associate observations with a secondary characteristic, for example, the operator who performed the assay, to evaluate at a glance which additional factors might be influencing your results.
  - 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.
  - 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
Details on the deployment and installation of licensed PLA 3.0 versions.
Licensing
Details on the licensing solution of PLA 3.0, the available licensing options, and the activation and management of licenses.
Administration
Details on system administration tasks such as setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
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.
PDF downloads
Download PDF guides of current and previous framework and add-on versions.
Sample lab
Meet the team of Stegmann Labs Inc. and use our sample laboratory to explore core features and functions of PLA 3.0.
Glossary
Find definitions of terms.

Document status

Configure severity levels for your rules and use the resulting document status to quickly ascertain the criticality of a rule violation.

Severity levels

You assign severity levels to control limits and control rules. If a rule is violated, the most critical status is propagated to the next level in the document structure, according to the following logic:

The status of control limits and control rules is propagated to the rule set they belong to. The rule set status is propagated to the chart that references the rule set. The chart status is propagated to the document itself, the highest level in the document structure.

The following severity levels are available:


Severity level	Description	Symbol
Alarm	If the rule is violated, the status is set to red.
Warning	If the rule is violated, the status is set to yellow.
Information	If the rule is violated, the status is set to green.

Example

In the following example, two charts are set up for a document. Chart 1 uses one rule set, Rule set A. Chart 2 uses two rule sets, Rule sets B and C. Rule set A uses Nelson rule 1 as control rule, with 'Alarm' set as the severity level. For each of the rule sets of chart 2, a control limit and a control rule are configured. The severity levels of the control limits are set to 'Alarm'. The severity level of Nelson rule 3 is set to 'Information', the severity level of WECO rule 4 to 'Warning'.

Rule violations are detected for three rules and are propagated to the document as follows:

For Chart 1, Nelson rule 1 is violated. The 'Alarm' status is propagated to Rule set A. Chart 1 is set to 'Alarm'.
For Chart 2, Nelson rule 3 and WECO rule 4 are violated. The status is propagated to their respective rule set. As the status of Rule set C is more critical, this status is propagated. The status of Chart 2 is set to 'Warning'.
For the document, the status of Chart 1 is more critical and is propagated. The document status is set to 'Alarm'.

The following figure visualizes the process:

Status propagation from rule to document level — Figure 1. Status propagation from rule to document level