PLA 3.0

 

PLA 3.0

software for biostatistical analysis

PLA 3.0 is a software for biostatistical analysis in Research and Development (R&D) and regulated environments. It is designed for biopharmaceutical and regulated industries and covers the whole lifecycle of the analytical procedure for your pharmaceutical product, from early development to production.

PLA 3.0 supports all types of biological potency assays according to European Pharmacopoeia chapter 5.3 and U.S. Pharmacopeia <111>, <1032>, <1033>, <1034>. Besides, PLA 3.0 supports interpolation and spike-and-recovery analysis as well as EC 50 calculation. For details on all supported methods, please have a look at our 'Analytical Methods'.

Key features of PLA 3.0 include:

Method lifecycle support. PLA 3.0 supports your method life cycle from early stages to development and operation. Develop your methods using documents. Implement your methods by saving your documents as templates.

Electronic documents. In PLA 3.0, all your data is stored in electronic documents. Documents are optimized for handling complex data structures. Each document contains a set of elements, with each element holding specific data.

 

Modularity. The PLA 3.0 framework is responsible for the integrity and reliability of measurement data. It provides security features employing user accounts, roles, and permissions. It also offers strong validation features for Installation Qualification and Operational Qualification. PLA 3.0 add-ons allow you to easily extend your work environment with new features. They provide extensions such as document types, report templates, data acquisition modules, and customer-specific modules.

 

Dose-Response Analysis Package

With PLA 3.0.5 we introduce a new add-on: The Dose-Response Analysis Package provides a range of additional biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves and it provides enhanced data processing and analysis. New document reports and dashboards add to its value and usability.

Always up to date with PLA 3.0

PLA 3.0.5 always keeps you informed about new extensions and developments. You can easily customize your work environment to get the most out of your installation.

Usability and performance improvements

Customers who already work with PLA will notice numerous improvements that enhance performance and usability. Our efforts to improve your experience with PLA have streamlined workflows and eliminated redundant tasks.

Feature overview

Our new PLA 3.0.5 features.

Dose-Response Analysis Package

• Various biostatistical methods

• Interpolation on calibration curves
• Spike-and-recovery analysis
• Linearity-of-dilution assessment
• Effective-concentration calculation
• Curve comparisons

• Equivalence for calibration curves

• Equivalence tests for calibration curves

• Equivalence tests for parameter estimates
• Point estimate tests for parameter estimates
• ANOVA terms

• Equivalence margin development for calibration curves

• Use your historic assay runs to develop acceptance criteria for calibration curves
• Test strategy development
• Visualizations
• Simulations

• Enhanced response data processing

• Data normalization and adjustment

• Use these features, for example, to subtract the absorbance of blank wells or to divide response values by the mean absorbance of maximum binding wells.

• Data transformation

• Logarithmic transformation
• Square transformation
• Square root transformation

• Average replicates
• Adjust the sequence of response data processing steps to your needs / Adjust the sequence of data processing steps

• Subgroup analysis

• Define any subgroups in your experiment

• Subgroups for single- and multi-dose samples
• E.g.: spike-and-recovery analysis
• E.g.: assay optimization

• Subgroup statistics of interpolated results and Dose-response curve characterization

• Averages
• Standard deviations
• Coefficient of variations
• Recovery rate
• Overlay plots

• New reports and document dashboards

• More informative document dashboards

• Document definition (e.g.: assay and test system setup)
• Calculation results (overview and in-depth information)
• Graphically improved data plots

• Revised design of reports and dashboards

• Provides greater lucidity
• Fresh and modern look
• Clear, uniformly applied layout and design
• Uniform color scheme in line with editors

 

New dashboard in PLA 3.0

• Stay informed on

• New developments around PLA 3.0.5
• Events related to PLA 3.0.5
• Information on the database
• Information posted by your organization
• Your license and support status

• Quickly access help and support

Revised data table handling

• Automatically sets up the data table as you develop a new assay document
• Automatically arranges the data table to match your plate layout
• Allows you to easily adjust your data table

• Employ alternate plate layouts
• Accommodate data acquisition
• Correct assignment errors

Refined user experience

• Faster editor, overall performance improvements
• More capable, 64-bit software platform
• New feature: just three mouse clicks to create up to 99 elements at a time

 

Method lifecycle

PLA 3.0 supports your method life cycle from early stages to development and operation. Develop your methods using documents. Implement your methods using templates. Just save any document as a template and reuse its settings every time you select the template.

Implement your Standard Operation Procedures (SOPs) within PLA 3.0:

• Set up access rights to allow only authorized users to define templates
• Prevent changes to a template setup by signing it
• Define the mandatory use of specific templates in the database or database sections

Set up templates per folder

You are free to control the use of templates for every folder in the database. This allows you to set up a specific range of templates to be available for a specific project. Just set up all required templates and allow a project team to access a specific subset only.