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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.
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.
Migrate
Migrate your 2.x assay data to PLA 3.0.
PLA 3.0 Migration and Archiving Toolkit
Use the PLA 3.0 Migration and Archiving Toolkit if you are running a PLA 2.0 or PLA 2.1 installation and want to migrate your databases to a PLA 3.0 environment.
Reference information
Find reference information on the document types of the PLA 3.0 Migration and Archiving Toolkit add-on.
PLA 2.x Assay comparison document type
The PLA 2.x Assay comparison document is the central document type for the comparison process, holding the information of a single assay comparison.
Document element reference
The document element reference is a technical reference about the details of all elements available in an Assay comparison document.

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.
- 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.
- 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.
  - Update
    Update your environment to PLA 3.0.7 to benefit from the latest innovations and improvements.
  - Upgrade
    Upgrade from PLA 2.1 or PLA 2.0 to the latest PLA 3.0 version and migrate your assay data.
  - Migrate
    Migrate your 2.x assay data to PLA 3.0.
    - PLA 3.0 Migration and Archiving Toolkit
      Use the PLA 3.0 Migration and Archiving Toolkit if you are running a PLA 2.0 or PLA 2.1 installation and want to migrate your databases to a PLA 3.0 environment.
      - Concepts
        The PLA 3.0 Migration and Archiving Toolkit utilizes a set of concepts that support you in transferring your data from a PLA 2.x source environment to a PLA 3.0 target environment.
      - Add-ons
        The PLA 3.0 Migration and Archiving Toolkit consists of several add-ons that cover different aspects of the archiving and migration process.
      - Document types
        The add-ons of the PLA 3.0 Migration and Archiving Toolkit provide a set of document types to archive and synchronize your assay data.
      - Work with the Toolkit
        Find details on the steps required to migrate your assay data from PLA versions 2.0 or PLA 2.1 to a PLA 3.0 environment.
      - Installation
        Find details on the installation of the PLA 3.0 Migration and Archiving Toolkit.
      - Reference information
        Find reference information on the document types of the PLA 3.0 Migration and Archiving Toolkit add-on.
        PLA 2.x Assay archive document type
        The PLA 2.x Assay archive document is the central document of the PLA 3.0 Migration and Archiving Toolkit. It holds all the archived information from a PLA 2.x assay.
        PLA 2.x Assay comparison document type
        The PLA 2.x Assay comparison document is the central document type for the comparison process, holding the information of a single assay comparison.
        Document structure
        The document structure shows the hierarchy of a PLA 2.x Assay comparison document.
        Document element reference
        The document element reference is a technical reference about the details of all elements available in an Assay comparison document.
        PLA 2.x Bulk comparison document type
        The PLA 2.x Bulk comparison document can automatically compare a huge number of migrated Quantitative response assays to their original PLA 2.x Assay archive documents.
        PLA 2.x Database synchronization document type
        The PLA 2.x Database synchronization document is the central document type for creating your archive. It holds a list of all synchronized projects and links the PLA 3.0 database to the synchronization folder.
        PLA 2.x Project synchronization document type
        The PLA 2.x Project synchronization document represents the original PLA 2.x project. It holds references to all PLA 2.x Assay archive documents.
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.

Document element reference

The document element reference is a technical reference about the details of all elements available in an Assay comparison document.

The following information is included in the document element reference:

Parent path to the element.
Label of the element
Identification number referencing the structure overview.
Technical name
Data type of the element
Default (Initial) value
Multiplicity (Minimum and maximum number of appearances)
Is the element required in the document?
Description of the element


_/ PLA 2.x Assay comparison document				001
_{TECHNICAL NAME} AssayComparison	_{DATA TYPE} xs:empty	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
The PLA 2.x Assay Comparison Document defines a comparison of a migrated Quantitative Response Assay to its source PLA 2.x Assay Archive Document.


_{/PLA Assay Comparison Document/} Name				002
_{TECHNICAL NAME} Name	_{DATA TYPE} xs:token	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
The name of the PLA 2.x Assay Comparison Document.


_{/PLA Assay Comparison Document/} Date				003
_{TECHNICAL NAME} Date	_{DATA TYPE} xs:dateTime	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
The date element is initially filled by the current date and time. It is possible to change the value of this element.


_{/PLA Assay Comparison Document/} Migrated Document Reference				004
_{TECHNICAL NAME} MigratedDocumentReference	_{DATA TYPE} Document Reference. Quantitative ResponseAssay	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Reference to the Quantitative Response Assay Document to perform the comparison.


_{/PLA Assay Comparison Document/} Report Full Precision Values				005
_{TECHNICAL NAME} ReportFullPrecisionValues	_{DATA TYPE} xs:boolean	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
If the report full precision values option is set to 'true', the compared values will be additionally reported with the unrounded value. Otherwise only the rounded values will be visible in the report.


_{/PLA Assay Comparison Document/} Comparison Settings				006
_{TECHNICAL NAME} ComparisonSettings	_{DATA TYPE} xs:empty	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Settings for the comparison operation.


_{/PLA Assay Comparison Document/Comparison Settings/} Regression Parameter Precision				007
_{TECHNICAL NAME} Parameter	_{DATA TYPE} T_Comparison Precision	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Controls the precision used for comparing regression parameter results. Both values are rounded to the given number of significant digits and compared afterwards. The rounding method is the so-called 'rounding half away from zero'. Examples '4 significant digits', the observed value is 0.011135, the rounded value is 0.01114. '3 significant digits', the observed value is 0.011135, the rounded value is 0.0111.


_{/PLA Assay Comparison Document/Comparison Settings/} Test Result Precision				008
_{TECHNICAL NAME} Testresults	_{DATA TYPE} T_Comparison Precision	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Controls the precision used for comparing suitability test results. Both values are rounded to the given number of significant digits and compared afterwards. The rounding method is the so-called 'rounding half away from zero'. Examples '4 significant digits', the observed value is 0.011135, the rounded value is 0.01114. '3 significant digits', the observed value is 0.011135, the rounded value is 0.0111.


_{/PLA Assay Comparison Document/Comparison Settings/} Potency Result Precision				009
_{TECHNICAL NAME} Potency	_{DATA TYPE} T_Comparison Precision	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Controls the precision used for comparing potency results. Both values are rounded to the given number of significant digits and compared afterwards. The rounding method is the so-called 'rounding half away from zero'. Examples '4 significant digits', the observed value is 0.011135, the rounded value is 0.01114. '3 significant digits', the observed value is 0.011135, the rounded value is 0.0111.


_{/PLA Assay Comparison Document/Comparison Settings/} Standard Error Precision				010
_{TECHNICAL NAME} StandardError	_{DATA TYPE} T_Comparison Precision	_{DEFAULT VALUE} ‒	_MULTIPLICITY 1..1	_REQUIRED yes
Controls the precision used for comparing standard error results of parameter estimates. Both values are rounded to the given number of significant digits and compared afterwards. The rounding method is the so-called 'rounding half away from zero'. Examples '4 significant digits', the observed value is 0.011135, the rounded value is 0.01114. '3 significant digits', the observed value is 0.011135, the rounded value is 0.0111.