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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.
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.
Reference information
Find reference information on the document types of the Measurement Documentation Package add-on.
Operator documents
Find details on the document structure of Operator documents and access reference information on particular document elements.

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.
  - 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.
    - Installation
      Find details on the system requirements for the Measurement Documentation Package add-on and the steps to install the add-on in your environment.
    - Operator
      Use Operator documents to document the operators involved in the measurement process. Each document represents a single operator.
    - Equipment
      Use Equipment documents to document the of type of equipment involved in the measurement process. Each document represents a single equipment.
    - Substance
      Use Substance documents to document substances involved in the measurement. Each document represents a single substance.
    - Reference information
      Find reference information on the document types of the Measurement Documentation Package add-on.
      - Operator documents
        Find details on the document structure of Operator documents and access reference information on particular document elements.
      - Equipment documents
        Find details on the document structure of Equipment documents and access reference information on particular document elements.
      - Substance documents
        Find details on the document structure of Substance documents and access reference information on particular document elements.
      - Document elements
        Find reference information on the document elements in the document types of the Measurement Documentation Package add-on.
      - Digest of document properties for data aggregation
        Find a list of property keys available for data aggregation in the Measurement Documentation Package add-on.
  - 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.

Operator documents

Find details on the document structure of Operator documents and access reference information on particular document elements.

Select a link to display reference information about the respective element.

Operator
.... Name
.... Title
.... Function
.... Department
.... Phone
........ Type
........ Number
.... e-Mail
........ Type
........ e-Mail Address
.... Contact Details
.... Comment
........ Subject
........ Text
........ Linked Document
........ Date
........ Author