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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 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.

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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
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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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Glossary
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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.

Note: Users can still add extra information to the signature.

About this task

PLA 3.0 provides default reasons for approval, review, and verification of documents. If you require other reasons, you change the default settings.

Procedure

To change the default signature templates:

On the System menu, select Database policies.
In the Database policies dialog, on the Signatures tab, under Document signatures, complete the following steps:
1. Next to Templates for electronic signatures, select Edit…
2. Enter the templates you require and select OK.
Confirm your settings with OK.

Result

The templates you set up are available in the Template list box of the Apply electronic signatures dialog. In the following example, the 'Quality Assurance' template has been added:

Additional template for application of electronic signatures — Figure 1. Additional template for application of electronic signatures