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Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Databases
Current regulations, such as 21 CFR 11.10 in the pharmaceutical industry, require you to ensure that only authorized individuals can access your systems, perform operations, and sign records. The database-driven approach of PLA 3.0 enables you to take major steps toward meeting these requirements.
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.
Actions and keys
You can identify each action recorded in the audit trail by a key.

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.
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.
- Databases
  Current regulations, such as 21 CFR 11.10 in the pharmaceutical industry, require you to ensure that only authorized individuals can access your systems, perform operations, and sign records. The database-driven approach of PLA 3.0 enables you to take major steps toward meeting these requirements.
  - Database types
    PLA 3.0 supports Microsoft SQL Server and SQLite databases.
  - Database creation
    PLA 3.0 supports local databases, databases shared on a local network, and databases used in a client-server scenario, thus allowing you to create databases for single users and multiple users in a shared environment.
  - 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.
        Schemas
        The following table lists the events recorded in audit trails for schemas and the keys used to represent them.
        Information packages
        The following table lists the events recorded in audit trails for information packages and the keys used to represent them.
        Add-ons, components, OQ packages, and OSGI bundles
        The following table lists the events recorded in audit trails for add-ons, components, QQ packages, and OSGI bundles, and the keys used to represent them.
        IQ, OQ, PQ
        The following table lists the actions recorded in audit trails for IQ, OQ, and PQ and the keys used to represent them.
        Users and sessions
        The following table lists the actions recorded in audit trails for users and sessions and the keys used to represent them.
        User groups
        The following table lists the actions recorded in audit trails for user groups and the keys used to represent them.
        User roles
        The following table lists the actions recorded in audit trails for user roles and the keys used to represent them.
        Folder properties, folder restrictions, and security contexts
        The following table lists the actions recorded in audit trails for folder properties, folder restrictions, and security contexts and the keys used to represent them.
        Database policies and database properties
        The following table lists the actions recorded in audit trails for database policies and database properties and the keys used to represent them.
        Database locks and system locks
        The following table lists the actions recorded in audit trails for database locks and system locks and the keys used to represent them.
        Database maintenance
        The following table lists the actions recorded in audit trails for user maintenance and the keys used to represent them.
        Object, data, and document
        The following table lists the actions recorded in audit trails for object, data, and document and the keys used to represent them.
        Attachments
        The following table lists the actions recorded in audit trails for attachments and the keys used to represent them.
        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
      Use the database maintenance to update the database tables, which contain data for each document.
- Add-on management
  The add-on management feature of PLA 3.0 provides a central interface to activate, deactivate, or remove add-ons. You can request trials or quotes, and view release dates and dependencies, ensuring consistent and version‑controlled functionality across your PLA 3.0 database.
- 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.
- Backup and restore
  To keep the integrity of your PLA 3.0 environment and prevent data loss, we recommend regularly backing up your data. Find details on the key areas to consider and practical guidance on backup and restore procedures within your PLA 3.0 environment.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Sample lab
Stegmann Labs serves as the sample lab for scenarios illustrating the use of PLA 3.0 across bioassay analysis workflows.
Glossary
Definitions of central terminology used in PLA 3.0.

Actions and keys

You can identify each action recorded in the audit trail by a key.

See the following topics for details: