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PLA 3.0 Knowledge Center
  • Get started
  • User interface
  • Key concepts
  • Data analysis
  • Data import
  • Installation
  • Licensing
  • Administration
  • Regulatory compliance
  1. Home
  2. 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.

  3. 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.

  4. Reference information

    Find reference information on the document types of the Measurement Documentation Package add-on.

  5. Operator documents

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

  • Get started

    Explore PLA 3.0, its key features and ongoing enhancements, and learn 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. Learn about the position factors and data aggregation features.

  • 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.

    • 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.

      • 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.

    • 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, installation, initial and advanced setup of PLA 3.0.

  • 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.

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
    

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