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Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
Templates
Templates let you predefine the analytical method and the assay layout. During routine use, you only need to enter your experimental data. Use templates when you want to run the same assay setup on a regular basis without changing the analytical parameters.

Get started
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
- Overview
  An overview of the concepts that define structure and behavior in PLA 3.0.
- Data aggregation
  Data aggregation in PLA 3.0 lets you automatically transfer data and results from source to target PLA 3.0 documents, thus supporting complex and compliant operations. Manually entering data in spreadsheets or other programs is not necessary.
- Data tables
  Data tables in PLA 3.0 act as containers for observation data or referenced data. You use them to configure the display of observation data and to set up automated data flows between PLA 3.0 documents, thus minimizing the need for manual interaction.
- Documents
  PLA 3.0 securely stores all your data within electronic documents. Documents are organized within a database and presented through a folder tree for easy navigation and access. Your data remains complete, accurate, and consistent throughout its life cycle, thus ensuring data integrity.
- Extensibility
  PLA 3.0 uses a modular architecture, consisting of a core system called framework and specialized modules referred to as add-ons. This design lets you extend the system's capabilities by integrating extra modules without modifying the core software.
- Flexible plate layouts
  PLA 3.0 supports flexible plate layouts that you can configure according to your experimental needs, such as microplates, tube racks, or agar plates. To define these layouts, you use position factors. They let you associate observation data with its physical location on the measurement system.
- Templates
  Templates let you predefine the analytical method and the assay layout. During routine use, you only need to enter your experimental data. Use templates when you want to run the same assay setup on a regular basis without changing the analytical parameters.
  - Create templates
    Create templates to standardize the setup of new documents. Documents created from templates inherit template settings like document structure, initial values, and protection settings for document elements.
  - Protection settings
    Use protection settings to restrict access to elements, and ensure correct usage of the template.
  - Use cases
    Templates are the main method for creating new documents in PLA 3.0. They support a variety of use cases, from the creation of single assays to the setup of control and monitoring mechanisms.
Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Data import
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Installation and update
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
Licensing
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Glossary
Definitions of central terminology used in PLA 3.0.

Templates

Templates let you predefine the analytical method and the assay layout. During routine use, you only need to enter your experimental data. Use templates when you want to run the same assay setup on a regular basis without changing the analytical parameters.

About templates

When transitioning an assay from development to routine use, using templates ensures that validated methods are applied consistently during assay execution, thus supporting compliance with standard operation procedures.

Figure 1. From development to routine use with PLA 3.0 templates

Development

Functional administrators use documents to develop analytical methods in a test environment. They set up the assay elements, the analytical methods, and the test system. To implement the method, they save this configuration document as a template.

To approve the developed methods and confirm that they are suitable for the intended use, quality assurance inspectors apply electronic signatures to templates.

Routine use

Templates support several experiment runs without requiring extra configuration by bioassay analysts or end users. These users commonly use the developed templates to create the documents they need to run experiments in the production system. They should only need to enter the experiment data, run the calculation, and report the results.

Note:

In contrast to standard documents, templates should not contain any data. Therefore, you cannot calculate them.

Get started with templates

Templates in PLA 3.0 behave like standard documents in that you can create and work with them in the same way. Unlike standard documents, they also include features that let you standardize assay setup, define which parts of the setup operators can adjust within predefined limits, and enforce consistent assay execution.

Most workflows follow these general steps:

You begin by creating a template from an existing assay document, and defining the document structure. For details, see the Create templates topic.
Next, you configure protection settings to specify which parts of the template setup operators can view or adjust within the limits defined by the template. For details, see the Protection settings topic.
Then, you use document restrictions to enforce the use of templates and prevent users from creating documents that are not created from templates. For details, see the Document restrictions topic.