Database setup

PLA 3.0 databases store all your data and also hold information such as user accounts and audit trail information. 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.

When logging in to PLA 3.0, users connect to a specific database, which sets their work environment for the session. We recommend you use separate databases for tasks that require different work environments. For example, use dedicated databases for testing purposes and keep them separate from production environments.

For help on how to use databases in PLA 3.0, please consult the »How-to Guide« Working with PLA 3.0 databases or watch the »Tutorial video« Create your first PLA 3.0 database. For details on the administration of PLA 3.0 databases in general, please go to Administration & Maintenance.


Make sure you keep your database administrator credentials in a safe place. We cannot restore them as they are not known to us. This is especially important if you configure your database policies such that user accounts whose password has reached maximum age are locked, as this also applies to the administrator account.


Deployment scenarios & Database types

You can install a licensed PLA 3.0 version in a variety of scenarios, depending on your system environment and business model. Commonly used scenarios include deployment for a single user or in a small environment, deployment in a multi-user environment, and deployment in a terminal server environment. For more details, please go to Deployment scenarios.

PLA 3.0 supports SQLite databases and Microsoft SQL Server databases. Both database types allow multiple users to share the access, but only Microsoft SQL Server databases are intended for simultaneous use.

SQLite databases

Use an SQLite database if you only have a small amount of data. You can create any number of SQLite databases. Create the database for the active user or all users of a computer. To make the database available for a small group of users, you can also place it in a shared folder or on a file server.

An SQLite database consists of a single database file. Copy, move, and backup actions can therefore be performed easily. Simultaneous use and remote access are not intended. Note: We recommend you regularly create a backup of the database file.

Microsoft SQL Server databases

To manage a medium to a large amount of data that should be simultaneously accessible by multiple users, we recommend using Microsoft SQL Server as the database server.