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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.
Authenticity
Authenticity of digital data verifies that data is genuine and comes from its purported source. 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.
Example 2: Sign with reason and credentials
Some regulations require signatures to employ at least two distinct identification components. You can follow this requirement if your users need to manually enter both user name and password provided that user name and password are not the same strings.

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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.
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.
- Integrity
  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.
- Authenticity
  Authenticity of digital data verifies that data is genuine and comes from its purported source. 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.
  - Example 1: Sign with reason
    If your organization requires standardized reasons for signing documents, you can set up the required reasons. When applying signatures, users can select one of the provided reasons.
  - Example 2: Sign with reason and credentials
    Some regulations require signatures to employ at least two distinct identification components. You can follow this requirement if your users need to manually enter both user name and password provided that user name and password are not the same strings.
- Confidentiality
  Data confidentiality ensures that data is protected from unauthorized access and disclosure, and that personal privacy and proprietary information is protected.
- 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.
- Validation
  Achieving compliance with ISPE GAMP^® 5 requires software to be validated in the target environment.
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Sample lab
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Glossary
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Example 2: Sign with reason and credentials

Some regulations require signatures to employ at least two distinct identification components. You can follow this requirement if your users need to manually enter both user name and password provided that user name and password are not the same strings.

Procedure

On the System menu, select Database policies.
In the Database policies dialog, on the Signatures tab, under General, activate the Requires user name option.
Confirm your settings with OK.

Result

Figure 1. Apply electronic signature dialog with enabled Requires user name option

Note: With the Requires user name option deactivated, PLA 3.0 automatically inserts the user name of the current user as read-only.