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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
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 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 policies
Control and document aspects of how users access individual databases. Set password policies and the system-idle lock, enable compliant electronic signatures, require users to specify why they change data, enable database templates, and more.
Attachments
Enable the use of manual attachments and specify the types of attachments users should be allowed to work with.

Get started
Explore PLA 3.0, its key features and ongoing enhancements, and learn 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. Learn about the position factors and data aggregation features.
Data analysis
Data analysis add-ons offer a wide range of capabilities, ranging from analytical methods over comprehensive analysis to assay workflows and statistical process control.
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, installation, initial and advanced setup of PLA 3.0.
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
  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 policies
        Control and document aspects of how users access individual databases. Set password policies and the system-idle lock, enable compliant electronic signatures, require users to specify why they change data, enable database templates, and more.
        Security
        Set the system-idle lock and password policies for individual databases to ensure that the passwords of authorized users are sufficiently strong and that users change their passwords as often as deemed necessary by your organization.
        Signatures
        Enable electronic signatures. Specify how signatures are created and how signed documents are handled to make signatures compliant with current regulations such as 21 CFR Part 11 in the pharmaceutical industry.
        Traceability
        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.
        Attachments
        Enable the use of manual attachments and specify the types of attachments users should be allowed to work with.
        Barcodes
        Set the barcode type used by PLA 3.0 and the size of the generated barcodes.
        Advanced
        Enable draft components, use of databases as templates, changes to document and folder keys, and automatic saving of new, unedited documents.
      - Database info
        Provide information on databases to improve navigation and support users who work with them.
      - Configuration report
        Create PDF reports to document and communicate pertinent information on database configurations. 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.
    - 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.
    - Database maintenance
      Use the database maintenance to update the database tables, which contain data for each document.
- 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 at Stegmann Labs, where PLA 3.0 plays an essential role in every step of bioassay management.
Glossary
Find definitions of terms.

Attachments

Enable the use of manual attachments and specify the types of attachments users should be allowed to work with.

Note: This setting does not impact the handling of automatically generated attachments such as the generation of plots during assay calculation.

Manual attachments section

The following items are available:


Item	Description
Modify attachments	Specifies whether users are allowed to modify manual attachments. Available options: Permitted: Users can modify manual attachments. Files only: Users can modify attachments of the type file only. Links only: Users can modify linked attachments only. Denied: Users cannot modify manual attachments. Tip: You can permit manual attachments in general and use permissions to set up restrictions on user-level.
Modify attachments of signed documents	Specifies whether users are allowed to modify manual attachments from signed documents. Available options: Permitted: Users can modify manual attachments of signed documents. Attach only: Users can only add additional attachments to signed documents. Denied: Users cannot modify manual attachments of signed documents.
Maximum size [KB]	Specifies the maximum size of a manual attachment in KB. The default setting is 1024.
Allowed / blocked file extension	Manage a list of file extensions that should explicitly be allowed or blocked as attachments. By default, .com and .exe files are blocked.