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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.
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.
Reference information
Find reference information on the document types of the Dose-Response Analysis Package add-on.
Dose-response analysis documents
Find details on the document structure of Dose-response analysis documents and access reference information on particular document elements.

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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.
  - Installation
    Find details on the system requirements for the Dose-Response Analysis Package add-on and the steps to install the add-on in your environment.
  - Dose-response analysis
    Use Dose-response analysis documents to perform curve comparisons and create calibration curves.
  - Equivalence margin development
    Use Equivalence margin development documents to utilize data of earlier assays to develop and verify test systems and export these systems to apply them in new assay development.
  - Test system definition
    Use the Test system definition document type to define a collection of suitability tests and corresponding margins for Dose-response analysis documents.
  - Use case: Determine total human thyroxine (T4)
    Thyroxine (T4) is a commonly measured thyroid hormone for diagnosis of the thyroid function. Determining the total quantity of human thyroxine in serum is a standard use case for interpolation on a calibration curve.
  - Reference information
    Find reference information on the document types of the Dose-Response Analysis Package add-on.
    - Dose-response analysis documents
      Find details on the document structure of Dose-response analysis documents and access reference information on particular document elements.
    - Equivalence margin development documents
      Find details on the document structure of Equivalence margin development documents and access reference information on particular document elements.
    - Test system definition documents
      Find details on the document structure of Test system definition documents and access reference information on particular document elements.
    - Document elements
      Find reference information on the document elements in the document types of the Dose-Response Analysis Package add-on.
- 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.
- 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
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Licensing
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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
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Glossary
Find definitions of terms.

Dose-response analysis documents

Find details on the document structure of Dose-response analysis documents and access reference information on particular document elements.

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Dose-response analysis
.... Name
.... Identification
.... Date
.... Documentation
........ Analysis purpose
........ Alternatives
............ Substance name
............ Substance reference
........ Substance identification
........ Substance batch/lot number
........ Substance sub-batch/sub-lot number
........ Substance variant
........ Substance class
........ Substance description
........ Operator
............ Alternatives
................ Operator name
................ Operator reference
............ Role
........ Reagent
............ Alternatives
................ Reagent name
................ Reagent reference
............ Reagent identification
............ Reagent batch/lot number
............ Reagent sub-batch/sub-lot number
............ Reagent variant
............ Reagent class
............ Reagent description
............ Amount
........ Equipment
............ Alternatives
................ Equipment name
................ Equipment reference
........ User variable
............ Key
............ Value
........ Data source
............ File name
............ Import time stamp
............ Import module identification
............ Import comment
.... Setup
........ Assay elements
............ Standard
................ Name
................ Observation group ID
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Alternatives
.................... Concentration: Defined by source material
........................ Analyte quantity per amount unit
............................ Numerical value
............................ Unit
........................ Amount of the source material
............................ Numerical value
............................ Unit
........................ Solvent volume
............................ Numerical value
............................ Unit
.................... Concentration: Defined by stock solution
........................ Numerical value
........................ Unit
................ Preparation scheme
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
............ Test sample (unknown)
................ Name
................ Observation group ID
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Alternatives
.................... Concentration: Defined by source material
........................ Analyte quantity per amount unit
............................ Numerical value
............................ Unit
........................ Amount of the source material
............................ Numerical value
............................ Unit
........................ Solvent volume
............................ Numerical value
............................ Unit
.................... Concentration: Defined by stock solution
........................ Numerical value
........................ Unit
................ Preparation scheme
................ Report group
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Exclude from analysis / invalid assay element
............ Control
................ Name
................ Observation group ID
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Alternatives
.................... Concentration: Defined by source material
........................ Analyte quantity per amount unit
............................ Numerical value
............................ Unit
........................ Amount of the source material
............................ Numerical value
............................ Unit
........................ Solvent volume
............................ Numerical value
............................ Unit
.................... Concentration: Defined by stock solution
........................ Numerical value
........................ Unit
................ Preparation scheme
................ Report group
................ Data selection scheme
................ Display color
................ User variable
.................... Key
.................... Value
................ Exclude from analysis / invalid assay element
........ Preparation schemes
............ Multi-dose scheme
................ Name
................ Number of replicates
................ Predilution factors
.................... Predilution factor
................ Alternatives
.................... Geometric sequence
........................ Number of steps
........................ Initial working concentration
........................ Base
.................... Linear sequence
........................ Number of steps
........................ Initial working concentration
........................ Delta
.................... Stepwise concentration sequence
........................ Working concentration
.................... Stepwise dilution sequence
........................ Initial working concentration
........................ Dilution factor
............ Single-dose scheme
................ Name
................ Number of replicates
................ Predilution factors
.................... Predilution factor
........ Report groups
............ Report group
................ Name
................ Information
........ Observation data
............ Observation source
............ Column: Document reference
............ Column: Section
............ Row order
............ Column: Observation group
............ Column: Sequence step
............ Column: Response value
................ Unit
............ Column: Well ID
................ Name
................ Property scope
................ Property key
................ Section key
............ Column: Technical-outlier flag
............ Column: Position factor
............ Alternatives
................ Column: Boolean
................ Column: Date
................ Column: Date/time
................ Column: Floating-point number
................ Column: Integer
................ Column: Memo (multiline text)
................ Column: Text
................ Column: Time
.... Analysis
........ Response data processing
............ Alternatives
................ Adjustment
.................... Alternatives
........................ No adjustment
........................ by Fixed value
........................ by Assay element
............................ Assay element
............................ Sequence step
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
........................ Plate scope
................ Normalization
.................... Alternatives
........................ No normalization
........................ by Fixed value
........................ by Assay element
............................ Assay element
............................ Sequence step
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
........................ Plate scope
................ Transformation
.................... Alternatives
........................ No transformation
........................ Logarithmic response transformation
............................ Logarithm base
........................ Square response transformation
........................ Square root response transformation
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
................ Replicate averaging
.................... Alternatives
........................ Deactivated
........................ Activated
........ Analytical model
............ Alternatives
................ Model: Linear
................ Model: 3-parameter logistic fit with fixed upper asymptote
.................... Alternatives
........................ Asymptote fixed by test sample or control sample
........................ Asymptote fixed by value
................ Model: 3-parameter logistic fit with fixed lower asymptote
.................... Alternatives
........................ Asymptote fixed by test sample or control sample
........................ Asymptote fixed by value
................ Model: 4-parameter logistic fit
................ Model: 5-parameter logistic fit
............ Alternatives
................ Logarithmic dose transformation
.................... Logarithm base
................ No dose transformation
........ Data selection schemes
............ Data selection scheme
................ Name
................ Alternatives
.................... No outlier detection
.................... Dixon test
........................ Alpha
........................ Recursive
........................ Operational sequence
........................ Outlier processing
.................... Grubbs test
........................ Alpha
........................ Recursive
........................ Operational sequence
........................ Outlier processing
.................... Standard deviation test
........................ n Sigma
........................ Operational sequence
........................ Outlier processing
.................... (Externally) studentized residuals test
........................ Alpha
........................ Recursive
........................ Outlier processing
................ Alternatives
.................... All sequence steps
.................... Range partial
........................ Step start
........................ Step stop
................ Response range
.................... Upper limit
.................... Lower limit
........ Additional calculations
............ Effective concentration
................ Percentile
................ Label
............ Transduction unit
................ Total number of cells
................ Maximal response
................ Unit
........ Suitability tests
............ Test system reference
............ Assay suitability tests
................ Alternatives
.................... F-test (hypothesis test)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Equivalence test (parameter estimate)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Mean squares (ANOVA)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Sum of squares (ANOVA)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Value of interpolation
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Interval of interpolation
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Width of interpolation interval
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Maximal number of outliers
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Maximal sequence step CV (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Response value range
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Effective concentration
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Response at effective concentration
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Transduction unit
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Recovery rate
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
............ Sample suitability tests
................ Alternatives
.................... F-test (hypothesis test)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Equivalence test (parameter estimate)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Mean squares (ANOVA)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Sum of squares (ANOVA)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Value of interpolation
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Interval of interpolation
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Width of interpolation interval
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Maximal number of outliers
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Maximal sequence step CV (%)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Response value range
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Effective concentration
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Response at effective concentration
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Transduction unit
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Recovery rate
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.... Settings
........ Graphics
............ Display horizontal lines
............ Display vertical lines
............ Label of the x-axis
............ Label of the y-axis
............ Show observations
............ Show error bars
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author