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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.
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.
Example 1: Set technical outlier state with reason
If your organization requires standardized reasons for setting the technical outlier state, you can set up the required reasons. When setting the state, users can select one of the provided reasons.

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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.
- 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.
- 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.
  - Example 1: Set technical outlier state with reason
    If your organization requires standardized reasons for setting the technical outlier state, you can set up the required reasons. When setting the state, users can select one of the provided reasons.
  - Example 2: Set technical outlier state with reason and credentials
    If your organization requires users to enter their user name and password together with a reason when setting the technical outlier state, you can set up your database policies so.
- Validation
  Achieving compliance with ISPE GAMP^® 5 requires software to be validated in the target environment.
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Example 1: Set technical outlier state with reason

If your organization requires standardized reasons for setting the technical outlier state, you can set up the required reasons. When setting the state, users can select one of the provided reasons.

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

About this task

The technical outlier state is seen as protected value. By default, PLA 3.0 allows changes to protected values without entering a reason.

Procedure

To change the default behavior:

On the System menu, select Database policies.
In the Database policies dialog, on the Traceability tab, under Changes to protected values, complete the following steps:
1. Next to Templates for reasons for change, select Edit…
2. Enter the templates you require and select OK.
From the Change technical outlier state list box, select Permitted with reason.
Confirm your settings with OK.

Result

The templates you set up are available in the Template list box of the Set technical outlier state dialog. In the following example, three templates have been added.

Templates for changing the technical outlier state — Figure 1. Templates for changing the technical outlier state