Glossary

Use the action bar on the left side of the document pane to access the editors and the dashboard and perform actions on your documents.

PLA 3.0 add-ons extend the functionality of the PLA 3.0 framework to include the analytical methods your users require and enable them to visualize, document, and report results.

During the installation, PLA 3.0 creates a folder to store the setup files of all your add-ons. You can modify the default path of the folder, for example, when setting up a central repository.

Use Analysis of Variance (ANOVA) to determine sources of variation in statistical models. ANOVA employs several methods to estimate variance in the data. It then tests to what extent the results agree.

An application server is a server that hosts applications or software that delivers a business application through a communication protocol.

The assigned potency is the potency of the standard preparation.

The assumed potency is the provisionally assigned potency of a preparation to be examined which forms the basis of calculating the doses that would be equipotent with the doses to be used of the standard preparation.

Audit trails provide secure electronic records that you can use to track who changed what, when, and why. Use the audit trail of PLA 3.0 to track and communicate events related to actions such as user access, changes in work environments, and changes to data and documents. PLA 3.0 provides both system and document audit trails. The system audit trail records all events of an individual database. The document audit trail records all events that relate to an individual document. The events provided by a document audit trail are a subset of those recorded in the system audit trail of the document's database. Some system events are not included in the document audit trails.

Authenticity of digital data verifies that data is genuine and comes from its purported source.

Biological assays are analytical methods to determine the concentration or potency of a substance by its effect on living cells (in vivo) or tissues (in vitro). In contrast to common physical or chemical methods, biological assays result in detailed information on the biological activity of a substance.

Data confidentiality ensures that data is protected from unauthorized access and disclosure, and that personal privacy and proprietary information is protected.

Use configuration profiles to configure how Data Acquisition Modules acquire data from an external system. You can, for example, configure the logic according to which you want to add imported values to the observation table. Each Data Acquisition Module comes equipped with a default configuration profile that you can activate when using the module for the first time in your environment. You can create additional configuration profiles and select the profile you want to use during the data acquisition process.

Configuration reports (also referred to as configuration item list or CIL) summarize the configuration of the database as it is presented to the user who creates the report.

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. In the case of biological assay documents, the dashboard shows document definitions and a graphical summary of calculation results.

Use the data acquisition feature of PLA 3.0 to import response values from external systems into existing PLA 3.0 documents. The acquired values are imported with traceability information (time stamp of the acquisition, the user who acquired the data, and original value) and details about the source file as well as the Data Acquisition Module used.

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.

Use data editors to enter observation data and set up assay layouts. Each editor has the same data but provides a different view on your data.

For details, see the Data editors topic.

PLA 3.0 supports a variety of plate layouts and plate types, such as 96-well or 384-well microplates and cylinder plates. It can import data from a variety of sources, such as text, XLS, and XLSX files. It also supports device-specific formats such as BioTek Gen5™ and Molecular Devices' SoftMax® Pro. PLA as such is not preconfigured for use with a specific plate layout or device.

Data integrity refers to the completeness, accuracy, and consistency of data over its entire life cycle. PLA 3.0 stores all your data in electronic documents, which are in turn stored in a database. When handling documents, PLA 3.0 utilizes digital signatures to ensure that documents are not tampered with.

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.

For details, see the Data tables topic.

Data selection schemes define which data are considered in the analysis. You can select, for example, which data points or dilution steps you want to include.

Use database connection profiles to connect to PLA 3.0 databases. These profiles hold all properties required to connect to a database such as the path where the database is located, the user name, and the encrypted password to access the database.

PLA 3.0 databases store all your data and also hold information such as user accounts, rights and permissions, signatures, and audit trail information. When logging in to PLA 3.0, users connect to a specific database, which sets their work environment for the session.

The document mode determines the purpose for which you can use a document. Three modes are available, that is, document, template, and PQ definition.

For details on the different mode, see the Documents, Templates, and Performance Qualification topics.

When you create a new or open an existing document, the document pane opens on the right side of the PLA 3.0 main window. This pane is your main area when working with documents.

Use document restrictions to enforce the use of templates and prevent users from creating documents that are not generated from templates. You can also set up restrictions such that folders can contain specific document types only.

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.

For details, see the Documents topic.

In PLA 3.0, users can employ electronic signatures to protect complete documents, document structures, and document data. Administrators can configure the handling of electronic signatures such that it supports regulatory compliance.

The estimated potency is the potency calculated from biological assay data.

The PLA 3.0 framework handles data as electronic documents. It provides the features you need to achieve regulatory compliance such as access control, data integrity, security, validation, and traceability.

Information packages play a central role in the installation and licensing process. They contain key data required to get PLA 3.0 up and running in your environment.

Information packages are specific to a serial number. They hold the PLA 3.0 license and a set of license keys. You need the license to run the PLA 3.0 framework and the license keys to run your PLA 3.0 add-ons.

For details on information packages, see the Information packages topic.

License keys regulate the use of PLA 3.0 add-ons, while software keys regulate the use of the PLA 3.0 software as such.

When you start PLA 3.0 for the first time, PLA 3.0 employs your information package to automatically make your license keys available. It also automatically updates them whenever the license status of an add-on changes, for example, when you request a trial license.

The use of the PLA 3.0 software is governed by licenses. The PLA 3.0 trial version runs without a license. To gain access to a fully functional version of PLA 3.0, you require a license.

To activate a PLA 3.0 license in your environment, you install a software key. How many users can work with the same license at the same time, that is, one user or several users, is determined by the licensing option.

For details on the licensing solution of PLA 3.0, see the Licensing topic.

The licensing option determines the number of users who can access PLA 3.0 at the same time. It also determines the number of computers on which you can install PLA 3.0. A Seat license can be used by only one user at a time. A Concurrent use license allows several users simultaneous access. All PLA 3.0 licensing options can be used in connection with SQLite and Microsoft SQL Server databases.

For details, see the Licensing options topic.

At the top of PLA 3.0 main window, the menu bar provides a series of sub-menus that you can use to access key features and functions of PLA 3.0, such as document and folder-related actions, database policies, and account management.

The Navigator on the left side of the PLA 3.0 main window is your main tool for accessing and organizing your documents and folders.

Observation data as such refers to the original and unprocessed data that you collect or generate during the operation of your analytical methods. For some PLA 3.0 document types, observation data is also used as the name of the data table that you use to prepare your PLA 3.0 document for processing.

A synonym for observation data is raw data. For details on how to work with observation data in PLA 3.0, see the Data editors topic.

Use the observation source setting to configure how you obtain your observation data. You can enter data manually or aggregate it from other PLA 3.0 documents. The observation source you select influences which data editors you use to enter your observation data.

Each assay element has a unique observation group ID assigned, linking the assay element to its respective observation data in the data editors. To switch plate positions for your samples, simply reassign the respective assay elements to a different observation group ID.

Use outlier detection to detect outlying response values. PLA 3.0 supports replicate-based outlier detection (Dixon, Grubbs, and Standard deviation tests) and model-based outlier detection (Studentized residuals test). How PLA 3.0 handles statistical outliers depends on the outlier processing setting. For example, you can exclude them from further analysis or mark them as outliers.

PLA 3.0 provides the features you need to control access to your data in a sophisticated and compliant manner. It combines role-based user rights with resource-based permissions, which enables you to exercise fine-grained control over who can perform particular tasks in a given context and which tasks are allowed with particular data.

Potency is a measure of drug activity expressed in terms of the amount required to produce an effect to given intensity. The more potent a drug the lower the amount required to produce the effect.

Potency data as such refers to data resulting from potency assays that are used to measure biological activity. In PLA 3.0, potency data is also used as the name of a data table that you use to prepare your PLA 3.0 document for processing.

The potency ratio is the ratio of equipotent doses of the standard preparation and the unknown preparation under the conditions of the biological assay.

Preparation schemes are your central tool for efficiently assigning settings to assay elements. Define doses and dimensions of your treatments once and use the setup for as many assay elements as you require. Entering redundant information is not necessary.

The relative potency expresses the biological activity of a sample preparation compared to a standard preparation.

Create reports to save and share your assay results. PDF reports contain the data available on the dashboard, enriched with details like the database that holds the document, and detailed calculation results for each assay element.

Use response data processing to configure the processing of response data, for example, to subtract the absorbance of blank wells or to divide response values by the mean absorbance of maximum binding wells.

Serial numbers consist of 5 digits and uniquely identify your PLA 3.0 license. Information packages are specific to a serial number.

Software keys regulate the use of the PLA 3.0 software as such, while license keys regulate the use of PLA 3.0 add-ons.

To activate your PLA 3.0 license, you install a software key on the computer or license server that should hold the PLA 3.0 license.

The stated potency or labeled potency, in the case of a formulated product, is a nominal value assigned from knowledge of the potency of the bulk material; in the case of bulk material the potency is estimated by the manufacturer.

Assays are based on curve similarity. Suitability tests allow you to check the validity of calculations every time they are performed.

Use templates to simplify tasks, standardize processes, and improve data security. Define document structures and initial values for documents, and control who can view and edit document sections and individual elements within documents.

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

For details, see the Templates topic.

Below the menu bar, the toolbar displays a set of icons that you can use for quick access to commonly used tools or functions, such as document and folder-related actions and report creation.

Traceability ensures logical data integrity, that is, you can trace your data across your entire system, from its current status back to its original source. In PLA 3.0, you can require users to specify why they modify documents and protected values to improve traceability and protect data from intentional and unintentional changes.

When aggregating data, the update mode defines how PLA 3.0 adds references to source documents and how it updates the data provided by the referenced documents.

Position factors in PLA 3.0 support you in defining plate layouts. They let you associate your observation data in PLA 3.0 with its physical location on a plate or rack.

For details, see the Position factors topic.