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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.

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 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, 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.
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. Stegmann Systems supports the validation of PLA 3.0 in the target environment through the PLA 3.0 Validation Package, which provides fully automated functions for Installation Qualification (IQ) and Operational Qualification (OQ).
- Quality governance
  Quality governance ensures a structured approach to maintaining and improving quality within Stegmann Systems. It covers the principles, processes, and verification steps we apply to achieve compliance, reliability, and continuous improvement in our development and validation practices.
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.

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.

Video: Traceability of data in PLA 3.0

Traceability settings

In PLA 3.0, traceability settings are part of the database policies. That is, you can set up individual rules for each of your databases.

Note: For a detailed description of the available settings, see the Traceability topic.

See the following topics for examples on the configuration of traceability:

Audit trail in PLA 3.0

Audit trails provide secure electronic records that you can use to track who changed what, when, and why. Use the audit trail of PLA 3.0 to track and communicate events related to actions such as user access, changes in work environments, and changes to data and documents.

PLA 3.0 provides both system and document audit trails. The system audit trail records all events of an individual database. The document audit trail records all events that relate to an individual document. The events provided by a document audit trail are a subset of those recorded in the system audit trail of the document's database. Some system events are not included in the document audit trails.

Note: For a detailed description of the available data and how to work with the audit trail, see the Audit trail topic.