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Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Supporting add-ons
Find details on add-ons that support and supplement data analysis add-ons.
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.
Reference information
Find reference information on the document types of the Generic Document Types add-on.
Document elements
Find reference information on the document elements in the document types of the Generic Document Types add-on.
S–Z
Find reference information on document elements of the Generic Document Types add-on, letters S to Z.
Table

Get started
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
Data analysis
Analytical methods, comprehensive analysis, 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.
    - Installation
      Find details on the system requirements for the Generic Document Types add-on and the steps to install the add-on in your environment.
    - Contact
      Use Contact documents to track communication details and contact information related to the current database, project, or folder.
    - Note
      Use Note documents to provide a note related to the current database, project, or folder.
    - Table
      Use Table documents to provide information on a table related to the current database, project, or folder.
    - Use cases
      Find details on how to use the document types of the Generic Document Types add-on in your daily business.
    - Reference information
      Find reference information on the document types of the Generic Document Types add-on.
      - Contact documents
        Find details on the document structure of Contact documents and access reference information on particular document elements.
      - Note documents
        Find details on the document structure of Note documents and access reference information on particular document elements.
      - Table documents
        Find details on the document structure of Table documents and access reference information on particular document elements.
      - Document elements
        Find reference information on the document elements in the document types of the Generic Document Types add-on.
        A–D
        Find reference information on document elements of the Generic Document Types add-on, letters A to D.
        E–L
        Find reference information on document elements of the Generic Document Types add-on, letters E to L.
        M–R
        Find reference information on document elements of the Generic Document Types add-on, letters M to R.
        S–Z
        Find reference information on document elements of the Generic Document Types add-on, letters S to Z.
        Salutation
        Section key
        Section key
        Section property filter
        Section property import
        Subject
        Table
        Template key
        Term
        Text
        Text
        Text
        Title
        Topic
        Type
        Type
        Type
        Update mode
        Update mode
        Website
        Website
  - 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.
  - 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
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Installation and update
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
Licensing
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Sample lab
Stegmann Labs serves as the sample lab for scenarios illustrating the use of PLA 3.0 across bioassay analysis workflows.
Glossary
Definitions of central terminology used in PLA 3.0.

Table

Table documents allow you to provide information on a table related to the current database, project, or folder.


Data type	Multiplicity	Usage	Default value
Node	1...1	required	none

Top level

Table

This element has the following attributes: