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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.
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).
Reference information
Find reference information on the document types of the Microbial Assays for Antibiotics Package add-on.
Cylinder-plate assay (USP <81>) documents
Find details on the document structure of Cylinder plate assay (USP <81>) documents and access reference information on particular document elements.

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.
- 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).
  - Installation
    Find details on the system requirements for the Microbial Assays for Antibiotics Package add-on and the steps to install the add-on in your environment.
  - Cylinder plate assays (USP <81>)
    Use Cylinder plate assay (USP <81>) documents to determine the potency of antibiotics according to the cylinder-plate method described in USP <81>. PLA 3.0 uses a linear regression model to fit the standard curve. This method allows you to correct for plate-to-plate variation.
  - Cylinder plate assays (JP 4.02)
    Use Cylinder plate assay (JP 4.02) documents to determine the potency of antibiotics according to the cylinder-plate method described in JP 4.02. PLA 3.0 compares the response values of the test sample at high and low concentration to the response of the standard at high and low concentration.
  - Turbidimetric assays (USP <81>/JP 4.02)
    Use Turbidimetric assay (USP <81>/JP 4.02) documents to determine the potency of antibiotics according to the turbidimetric methods described in USP <81> and JP 4.02. PLA 3.0 uses a linear regression model to fit the standard curve.
  - Combination of microbial assays
    Use Combination of microbial assays documents to aggregate data of samples contained in any number of microbial assay documents, apply confidence limits, check for outliers, perform combination of assays calculations, and define statistical tests.
  - Literature
    The methods and procedures provided by the Microbial Assays for Antibiotics Package are based on use cases and requirements from literature.
  - Reference information
    Find reference information on the document types of the Microbial Assays for Antibiotics Package add-on.
    - Cylinder-plate assay (USP <81>) documents
      Find details on the document structure of Cylinder plate assay (USP <81>) documents and access reference information on particular document elements.
    - Cylinder-plate assay (JP 4.02) documents
      Find details on the document structure of Cylinder plate assay (JP 4.02) documents and access reference information on particular document elements.
    - Turbidimetric assay (USP <81>, JP 4.02) documents
      Find details on the document structure of Turbidimetric assay (USP <81>/JP 4.02) documents and access reference information on particular document elements.
    - Combination of microbial assays documents
      Find details on the document structure of Combination of microbial assays documents and access reference information on particular document elements.
    - Document elements
      Find reference information on the document elements in the document types of the Microbial Assays for Antibiotics Package add-on.
    - Digest of document properties for data aggregation
      The following table shows the property keys available for data aggregation
- 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.

Cylinder-plate assay (USP <81>) documents

Find details on the document structure of Cylinder plate assay (USP <81>) documents and access reference information on particular document elements.

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

Cylinder-plate assay (USP <81>)
.... Name
.... Date
.... Documentation
........ Assay 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
.................... Configuration
........................ Update mode
............ 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
.................... Configuration
........................ Update mode
........ User variable
............ Key
............ Value
........ Data source
............ File name
............ Import time stamp
............ Import module identification
............ Import comment
........ Inoculum
............ Test organism
................ Species
................ Incubation
.................... Duration
.................... Temperature
.................... Incubation medium
........................ Ingredient
............................ Ingredient name
............................ Ingredient amount
........................ pH
............ Inoculum medium
................ Ingredient
.................... Ingredient name
.................... Ingredient amount
................ pH
............ Inoculum concentration
............ Inoculum volume per plate
........ Base layer
............ Medium
................ Ingredient
.................... Ingredient name
.................... Ingredient amount
................ pH
............ Volume per plate
........ Incubation
............ Duration
............ Temperature
.... Setup
........ Assay design
............ Cylinders per plate
............ Reference measurements per plate
............ Plate replicates
........ Assay elements
............ Standard
................ Name
................ Reference step group ID
.................... Observation group ID
................ Observation group ID
................ Display color
................ Stepwise concentration sequence
.................... Alternatives
........................ Concentration step
............................ Step name
............................ Concentration
........................ Refence step
............................ Step name
............................ Concentration
.................... Concentration unit
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
............ Test sample (unknown)
................ Name
................ Observation group ID
................ Display color
................ Predilution
................ Combination group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Exclude from analysis / invalid assay element
............ Control
................ Name
................ Observation group ID
................ Display color
................ Predilution
................ Combination group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Exclude from analysis / invalid assay element
........ Observation data
............ Observation source
............ Column: Document reference
............ Column: Section
................ Name
................ Column key
................ Property filter
.................... Property key
.................... Term
............ Row order
............ Column: Observation group
............ Column: Sequence step
............ Column: Response value
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Unit
............ Column: Technical-outlier flag
............ Column: Position factor
............ Column: Position factor
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Number of positions
................ Map index to characters
............ 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
................ Normalization
.................... Alternatives
........................ No normalization
........................ by Fixed value
........................ by Assay element
............................ Assay element
............................ Sequence step
................ Transformation
.................... Alternatives
........................ No transformation
........................ Logarithmic response transformation
............................ Logarithm base
........................ Square response transformation
........................ Square root response transformation
........ Alternatives
............ Logarithmic dose transformation
................ Logarithm base
............ No dose transformation
........ Sample correction method
........ Test system
............ Assay suitability tests
................ Alternatives
.................... Test: Sample - Mean response
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Correction point
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Correction point - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Correction point - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Plate correction
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Type (R²)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Potency of the working sample
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Absolute potency
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Relative potency (percentage of reference concentration)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
............ Sample suitability tests
................ Alternatives
.................... Test: Sample - Mean response
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Correction point
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Correction point - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Correction point - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Plate correction
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Type (R²)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Potency of the working sample
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Absolute potency
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Relative potency (percentage of reference concentration)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author