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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.
Databases
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.
Database administration
Use the database administration features to set up, monitor, and maintain your PLA 3.0 database system.
Database monitoring
Monitor user sessions and document locks. Maintain a permanent record of all relevant events related to user access, changes in work environments, and changes to data for each individual PLA 3.0 database and document.
Audit trail
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.

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.
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.
- Databases
  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.
  - Database connections
    You can connect PLA 3.0 to multiple databases. Since most settings in PLA 3.0 apply to individual databases, you can differentiate, for example, between production and test databases, catering to tasks that require different work environments.
  - Database templates
    To enable you to create new databases more efficiently, PLA 3.0 provides a database template feature. This feature allows you to use existing SQLite databases as templates for the creation of new databases.
  - Database administration
    Use the database administration features to set up, monitor, and maintain your PLA 3.0 database system.
    - Database settings
      Establish consistent policies for a range of features, such as passwords, signatures, and traceability, that control and document user access to individual databases.
    - Database monitoring
      Monitor user sessions and document locks. Maintain a permanent record of all relevant events related to user access, changes in work environments, and changes to data for each individual PLA 3.0 database and document.
      - Session management
        View and manage the sessions of all users who are currently connected to the database.
      - Audit trail
        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.
        Event list
        The upper table of the Audit trail tab lists all recorded actions.
        Action details
        The lower table of the Audit trail tab displays all affected elements and their values.
        Actions and keys
        You can identify each action recorded in the audit trail by a key.
        Filter audit trail entries
        Apply filters to view only a subset of the available audit trail entries, for example, entries created on a specific date or by a specific user.
        Export audit trail entries
        Export audit trail entries to make them available in a log file, for example, if you want to print them out.
    - Database maintenance
      Perform database maintenance.
- Extensibility with add-ons
  PLA 3.0 consists of a framework and add-ons. 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.
- Rights and permissions
  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.
- Update, upgrade, and migrate
  Find details on how to update, upgrade or migrate your environment to work with the latest version of PLA 3.0.
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.

Audit trail

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.

Note: Users require permissions to access audit trails.

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.

Navigation: System > Audit trail (system audit trail) / Open document > action bar > Audit trail (document audit trail)

The following figure shows the Audit trail tab, displaying the system audit trail:

Audit trail tab of PLA 3.0 — Figure 1. Audit trail tab of PLA 3.0

The following items are available:


No.	Item	Description
1	Toolbar	Provides advanced features to enhance the experience of users who work with audit trails. Filter: Filter the entries of individual audit trails by user, date, action, and object. For details, see the Filter audit trail entries topic. Export: Export entire audit trails or the entries provided by previously defined filters. For details, see the Export audit trail entries topic.
2	Event list	Audit trails record all user log in and log out events of individual databases, all changes to the database settings, and all changes to the documents saved in the database, starting with document creation. Every event creates an entry in the audit trail. For details on the data available for an event, see the Event list topic. For details on the actions and their keys recorded in audit trails, see the Actions and keys topic. Tip: Double-click an entry to view extended audit trail details in a separate dialog.
3	Action details	Details on the action that created the event and all elements affected by the action, together with their values. For details, see the Action details topic. Tip: Double-click an entry to view extended audit trail details in a separate dialog.