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Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
Supporting add-ons
Find details on add-ons that support and supplement data analysis add-ons.
PLA 3.0 Migration and Archiving Toolkit
Use the PLA 3.0 Migration and Archiving Toolkit if you are running a PLA 2.0 or PLA 2.1 installation and want to migrate your databases to a PLA 3.0 environment.
Work with the toolkit
Find details on the steps required to migrate your assay data from PLA 2.x to a PLA 3.0 environment.
Compare PLA 2.x results with PLA 3.0
Set up the comparison logic to compare the calculation results of the migrated PLA 3.0 Quantitative response assays with the results in the PLA 2.x Assay archive documents.

Get started
Get an overview of PLA 3.0, the end-to-end bioassay analysis software. Learn about its ongoing improvements and version updates, and discover the available trial options.
Key concepts
Learn how the key concepts of PLA 3.0 form the structural foundation for your daily work, supporting method development from initial design to routine production.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
- 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 the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
- 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.
- 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.
- 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).
- Supporting add-ons
  Find details on add-ons that support and supplement data analysis add-ons.
  - 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.
  - Generic Document Types
    Use the Generic Document Types add-on to organize contact-related data, create and manage reminders or internal comments, or streamline workflows where data needs to be consistently organized and referenced.
  - 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
    The Measurement Documentation 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.
  - PLA 3.0 Migration and Archiving Toolkit
    Use the PLA 3.0 Migration and Archiving Toolkit if you are running a PLA 2.0 or PLA 2.1 installation and want to migrate your databases to a PLA 3.0 environment.
    - Installation
      Find details on the installation of the PLA 3.0 Migration and Archiving Toolkit.
    - Work with the toolkit
      Find details on the steps required to migrate your assay data from PLA 2.x to a PLA 3.0 environment.
      - Export PLA 2.x data
        Find details on how to export PLA 2.x data to the hard drive.
      - Archive PLA 2.x data in PLA 3.0
        Set up an archive of your PLA 2.x assays in your PLA 3.0 environment.
      - Migrate PLA 2. x assays into PLA 3.0 documents
        Set up the migration logic to convert your PLA 2.x assays into PLA 3.0 Quantitative response assay documents. You can convert a single document or all documents within a project.
      - Compare PLA 2.x results with PLA 3.0
        Set up the comparison logic to compare the calculation results of the migrated PLA 3.0 Quantitative response assays with the results in the PLA 2.x Assay archive documents.
        Add-on used
        Find the list of add-ons that support you during the comparison of PLA 2.x and PLA 3.0 data.
        Compare a single assay
        Compare the calculation results of a single PLA 2.x Assay archive document with the calculation results of the corresponding migrated PLA 3.0 Quantitative response assay.
        Compare all assays in a project
        Compare the calculation results of all PLA 2.x Assay archive documents in a project with the calculation results of the corresponding migrated PLA 3.0 Quantitative response assays (bulk comparison).
    - Reference information
      Find reference information on the document types of the PLA 3.0 Migration and Archiving Toolkit add-on.
  - 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.
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.
Installation and update
Details on deployment, installation, and update of PLA 3.0, and its initial and advanced setup.
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 at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
Glossary
Find definitions of terms.

Compare PLA 2.x results with PLA 3.0

Set up the comparison logic to compare the calculation results of the migrated PLA 3.0 Quantitative response assays with the results in the PLA 2.x Assay archive documents.

Before you begin

Make sure the PLA 2.x Comparison Package add-on is activated in the PLA 3.0 database.
Complete the steps described in the Migrate PLA 2. x assays into PLA 3.0 documents topic.

About this task

Once migrated, you have to find out if the calculation results in the target environment are identical or about identical (PLA 3.0 has an enhanced precision in several processes) to the calculation results in the source environment. The comparison process delivers a comparison report for single assays as well as for complete projects. This lets you compare any number of assays at one glance.

You can use this comparison to requalify your methods. The Comparison process compares the most relevant data of the PLA 2.x and PLA 3.0 results. These are especially:

Parameter estimates and their standard errors
Regression results
ANOVA results
Test results for the defined test system
Selected ranges
Potency results

PLA 3.0 compares the values using specific comparison classes, where each class can have its own comparison precision. The following classes are available:

Regression parameter
Test result
Potency result
Standard error

Note: Depending on the nature of your assay system, you may have to modify this precision.

Procedure

You can compare the calculation results of a single assay, or of all assays within a project:

Compare a single assay.
Compare all assays in a project.

How-to video

The following video shows how to compare PLA 2.x results with PLA 3.0: