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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.
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.
Structure of the reports
The reports in the additional report file formats generated by the Integration Report Package share the same content and the general structure. The order and the detailed structure depend on the file format.

Get started
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.
- 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.
  - Installation
    Find details on the system requirements for the Integration Report Package add-on and the steps to install the add-on in your environment.
  - Create reports
    Reports summarize the details and the results of an action that was executed on a document. You can create reports for a single document or for multiple documents. The Integration Report Package allows you to create reports in file formats additionally to the standard PLA 3.0 reports file formats like PDF.
  - Available file formats
    The Integration Report Package can create reports in various file formats that are not covered by the default report formats available in the Biological Assay Package. You can use these reports to import the data into other systems, or you can access the data in these reports with third-party software.
  - Structure of the reports
    The reports in the additional report file formats generated by the Integration Report Package share the same content and the general structure. The order and the detailed structure depend on the file format.
- 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.

Structure of the reports

The reports in the additional report file formats generated by the Integration Report Package share the same content and the general structure. The order and the detailed structure depend on the file format.

The general content elements are as follows:


Content	Description
Metadata / information	Details like document key, title, version, type, creation and modification information (with user and time-stamp).
Setup	Configuration of the experiment, including the following elements: Elements involved (for example standards and test samples) with their respective group IDs, preparation schemes, and color codes. Preparation schemes: Detailed steps for preparation, including the step count, replicate count, potency definitions, and dilution factors. Dataset: Information on observation sources, observation groups (with IDs and values), and specific details for each step of the experiment, including dose values, responses, and outlier status.
Analysis	Model used for analysis (for example 3-parameter logistic fit with fixed upper asymptote), response transformation details, data selection schemes, and tests conducted for assay suitability and sample suitability.
Execution	Execution details, including the user, start and stop times, host information, and platform details.
Status	Overall status of the analysis, indicating if it passed, failed, or passed with warnings.
Assay results	Results, including the following entities: Actual detailed results for each assay element, including base statistics (mean, standard error, coefficient of variation) for each step, model fit results, potency estimates, and summary. Suitability test definitions: Specifics on the types of suitability tests conducted, including parameters like confidence level, scope, and severity.

Note: Depending on the file format of the report, the order of the content as well as the inner structure can differ from the one shown in the table.