Home
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.
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.
Operator
Use Operator documents document the operators involved in the measurement process. Each document represents a single operator.
Work with Operator documents
Use the Content editor to add and edit data about the operator and create links to other documents.

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.
  - 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 document the operators involved in the measurement process. Each document represents a single operator.
    - Dashboard
      Use the document dashboard on the right side of the PLA 3.0 main window to get an overview of your document data and view recent changes.
    - Work with Operator documents
      Use the Content editor to add and edit data about the operator and create links to other documents.
  - 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.
- 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.

Work with Operator documents

Use the Content editor to add and edit data about the operator and create links to other documents.

Note: With the Measurement Documentation Package, you can create links to Contact documents. To do so, you need to activate the Generic Document Types Package add-on.

Elements and their function

The following figure shows a Operator document displayed in the Content editor of PLA 3.0.

Figure 1. Content editor of an Operator document

Use the Creatable Elements pane to add the elements you require. To edit an existing entry, double-click the element in the Element pane.


Element	Description	Specification	Wiki notation available
Name	The name of the operator.	required	no
Title	The academical title of the operator.	optional	no
Function	The job function or job title of the operator.	optional	no
Department	The department of a company or organization where the operator is located.	optional	no
Phone	Phone type (for example, mobile) and number.	optional, several elements are possible	no
e-Mail	E-Mail type (for example, work) and address.	optional, several elements are possible	no
Contact details	A link to a contact document with full contact details.	optional, several elements are possible	no
Comment	Comments with subject, text, date, author and the possibility to create links to other documents. You can create several text entries and links to other documents in one comment element.	optional, several elements are possible	yes

Simplified Wiki notation

Some Text elements with an M symbol () support the use of a simple Wiki notation to provide formatting capabilities. Typically, these Text elements require formatting because they consists of several sentences, such as comments or journal entries. You can add a text with headlines and several lines.

The following markups are supported:


Markup	Formatting	Sample
=H1=	Heading Level 1	=Main Heading=
==H2==	Heading Level 2	==A second level heading==
…
=====H5=====	Heading Level 5	=====A fifth Level Heading=====
* Bullet List	Bullet List Level 1	* Sample
** Bullet List	Bullet List Level 2	** Level 2 Sample
# Numbered List	Numbered List Level 1	# Sample
## Numbered List	Numbered List Level 2	## Sample Level 2
bold	Bold Markup	Sample
_italic_	Italic Markup	_Sample_

Tip: If you write a text with several lines or paragraphs, press Alt + Enter to start a new line.