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PKS Validation Suite™ provides the following tests. Any or all can be included in a validation run. The suite of tests covers all major PKS Server and Client functions and options.

Automated Tests

  • Base_Study_History_Study: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, and modifying study data, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test cases Study_Data_History and Study_Meta_Data_History.
  • Base_Study_1_Model_200: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, modeling the study data using NCA model 200 in WinNonlin, and saving the modeling results as a scenario, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test cases View_Study_Data, Merge_Scenario, and WNL_Study_Access_all.
  • Base_Study_2_Model_200: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, modeling the study data using NCA model 200 in WinNonlin, and saving the modeling results as a scenario, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test cases Merge_Scenario and WNL_Study_Access_all.
  • Base_Study_QT_UNIT1: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, modeling the study data using NCA model 200 in WinNonlin, and saving the modeling results as a scenario, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Query Tool.
  • Base_Study_QT_UNIT2: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, modeling the study data using NCA model 200 in WinNonlin, and saving the modeling results as a scenario, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test cases Query_Tool and Unit Conversion option in the Query Tool.
  • Study_for_Unit_Conversion: Automates the process of creating a PKS Study using WinNonlin and a PKS mapping file by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Unit_Conversion.
  • Study_for_Study_Deletion: Automates the process of creating a PKS Study using WinNonlin and a PKS mapping file by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Study_Deletion.
  • Study_for_Study_Append/Update: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, and appending dosing and demographics worksheets to the study, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used to test the WinNonlin integration between PKS for updating a study.
  • Study_for_Write_None: Automates the process of creating a PKS Study using WinNonlin and a PKS mapping file by a PKS user with WriteNone (system/all study) access. This PKS study will be used during execution of the manual test case WNL_Study_Access_all.
  • Pharsitol_Bioequivalence_Example: Automates the process of creating the Pharsitol Bioequivalance Example using WinNonlin and a PKS mapping file. The study is loaded and the 'PKS --> Other Documents' integration is tested with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case View_Scenario_Contents and the PKS Reporter 1.2.x integration automated test case.

PKS Client 3.0

  • Base NONMEM Study: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, running the study in NONMEM, and saving the NONMEN output as a scenario in PKS, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Study Data History.
  • Base SAS Study: Automates the processes of creating a PKS Study using WinNonlin and a PKS mapping file, running the study in SAS, and saving the SAS output as a scenario in PKS, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Study Data History.
  • Base S-Plus Study: Automates the processes of running a study in S-Plus, and saving the S-Plus output as a scenario in PKS, by a PKS user with WriteWrite (system/all study) access. This PKS study will be used during execution of the manual test case Study Data History.

PKS Office Client 3.0

  • MS Word: Automates the process of creating a PKS Study using a Microsoft Word document as the source of the study data by a PKS user with WriteWrite (system/all study) access. The test case tests the integration of Word to the PKS.
  • MS Excel: Automates the process of creating a PKS Study using a Microsoft Word document as the source of the study data by a PKS user with WriteWrite (system/all study) access. The test case tests the integration of Excel to the PKS.

PKS Reporter 1.2.x

  • Automates the processes of saving a report template to PKS, using the report template to create a new report and adding tags to the report, and saving the report to PKS, by a PKS user with WriteWrite (system/all study) access. The test case tests the integration of Reporter to the PKS.

Manual Tests

DBA_Prior_To_Automation

  • Create_User_Role_Admin-DBA.doc: Demonstrates the ability of a PKS Database Administrator to add and delete roles, to add new PKS users, and to assign role privileges to the users. The user will be required to access the PKS Web Admin with a DBA account to perform the required security functions.

Security_&_Prerequisities

  • WriteNone.doc: Reviews the ‘Administer Security’ menu item within PKS. The user will be required to grant study access to the user with ‘WriteNone’ privileges. This test will ensure the user with ‘WriteNone’ privileges is able to access the granted study.
  • ReadRead.doc: Demonstrates the PKS user’s ability to access Studies/Scenarios. The user has system access of “Read” and PKS access of “Read”. The “ReadRead” user will be granted administrative rights to a study within PKS. The “ReadRead” user will be able to grant access to other user’s when specifically relating to the study with “Admin” privileges.
  • ReadNone.doc: Demonstrates the PKS user’s ability to grant Study access to specific user accounts. The user will be required to access the study for which the study access was granted.
  • Audit_Reasons.doc: Demonstrates that a PKS user with Write system access can create system attribute (Audit Reasons) values for system attributes.
  • Custom_Study_Attributes_Admin.doc: Demonstrates the “Modify System Attributes – Custom Study Attributes” options in the PKS. The intent of this option is to give users the ability to add additional study filtering. This test case will also demonstrate the user’s ability to Add and Delete Groups, and Attributes.
    Note: The attributes can be deleted at any time. The attribute is not ‘locked in’, i.e. the study filter is not a dependent attribute to the study, as Study Design is.
  • WNL Study Access-all.doc: Verifies the user’s ability to change Study data when different user privileges are applied. The user will be required to open the WinNonlin application, connect to PKS using the preset User accounts, and try to perform updates to study data.

Write_test_Cases

  • Study_Design.doc: Demonstrates that a PKS user with Write system access can create system attribute (Study Designs) values for system attributes.
  • Study_Types.doc: Demonstrates that a PKS user with Write system access can create system attribute (Study Types) values for system attributes.
  • Blinding_Types.doc:Demonstrates that a PKS user with Write system access can create system attribute (Blinding Types) values for system attributes.
  • Analytical_Methods.doc:Reviews the Modify System Attributes - Blinding Types option in the PKS. demonstrate that a PKS user with Write system access can create system attribute (Analytical Methods) values for system attributes.
  • Observation_Status.doc: Demonstrates that a PKS user with Write system access can create system attribute (Observation Status) values for system attributes.
  • Manage_Units.doc: Demonstrates that a PKS user with Write system access can add a new Unit Category, add a new Unit to a Unit Category, add a new Conversion Factor.
  • Modify_Study_Information.doc: Demonstrates that a PKS user with Write system access can modify existing study attributes.
  • LockUnlock_Study.doc: Demonstrates that a PKS user is able to “Lock” and “Unlock” a PKS Study. The user will be required to open WinNonlin and access the Locked PKS Study.
  • Study_Meta_Data_History.doc: Demonstrates that changes made to Study Meta Data are accurately displayed in the Study Meta Data History.
  • Study_Data_History.doc:Demonstrates that changes made to Study Data are accurately displayed in the Study Data History.
  • View_Study_Data.doc: Demonstrates that a PKS user is able to retrieve study data using the “View Study Data” dialog. This test case also demonstrates the user is able to create filters using the “Custom Attributes Filter” to narrow searches within PKS.
  • View_Scenario_Contents.doc: Demonstrates that a PKS user is able to use the “Scenario Contents” dialog to view and download objects contained within PKS Scenarios. The user will be required to select a predetermined scenario, open the scenario contents, and download the scenario contents.
  • LockUnlock_Scenario.doc: Demonstrates that a PKS user is able to “Lock” and “Unlock” a PKS Scenario. The user will be required to open WinNonlin and access the Locked PKS Scenario.
  • Additional_Data_History_Report.doc:
    Demonstrates that the “Additional Data History Reports” contains data not represented in the “Study Data History”. The information in the Additional Data History Reports lists attribute and blob, creation and deletion. Also, the scenario lock will be part of the review.
  • Unit_Conversions.doc:Uses the ‘Unit Conversions’ within the PKS. Demonstrates the ability to change and convert units of measure within a PKS study.
  • Query_Tool.doc: Uses the ‘Query Tool’ within the PKS. This test case will exercise the basic functionality of the Query Tool. This test case provides the user the necessary information needed to create, save, and output data from PKS studies.

    Note: If the user decides to verify the data, the user has two options:
    1. Review the output supplied within the Pharsight PKS Validation Suite.
    2. Open each dataset and review the generated output created by the Query Tool.
  • View_System_Objects.doc: Uses the ‘View System Objects’ within PKS. This test case verifies the user’s ability to access and open objects within PKS Scenarios. The user will be required to select and download various object types. Each object type will open the associated software.
  • Merge_Scenario_Datasets.doc:Demonstrates that a PKS user is able to merge datasets. This user will select two PKS Scenarios, align the linking fields, and generate output from the merged dataset.

Read_Test_Cases

  • Modify_User_Information.doc:Demonstrates that a PKS user with Read system access can change the user’s own user information, e.g., name and e-mail address.
  • Query_Tool_Read.doc: Uses the ‘Query Tool’ within the PKS for the read user. The test case will exercise the basic functionality of the Query Tool for a user with Read System and Read Study access. The user will create and download the query.
  • Change_Password.doc: Demonstrates that a PKS user is able to change hisown PKS password. The user will then be required to login using the newly created password.

Admin_Test_Cases

  • Study_Design_Admin.doc: Demonstrates that a PKS Admin user can add a new Study Design attribute value, modify an existing Study Design attribute value, and delete a Study Design attribute value that is not in use by any studies.
  • Study_Types_Admin.doc: Demonstrates that a PKS Admin user can add a new Study Type attribute value, modify an existing Study Type attribute value, and delete a Study Type attribute value that is not in use by any studies.
  • Blinding_Types_Admin.doc: Reviews the “Modify System Attributes - Blinding Types” option in the PKS. Demonstrates the user’s ability to modify existing “Blinding Types”, create new Blinding Types, delete unused Blinding Types, and verify a used Blinding Types cannot be deleted.
  • Analytical_Methods_Admin.doc: Reviews the ‘Modify System Attributes – Analytical Methods’ option in the PKS. Demonstrates the user’s ability to modify existing “Analytical Methods”, create new Analytical Methods, delete unused Analytical Methods, and verify a used Analytical Method cannot be deleted.
  • Observation_Status_Admin.doc: Reviews the “Modify System Attributes – Observation Status” option in the PKS. Demonstrates the user’s ability to modify an existing Observation Status, create a new Observation Status, delete an unused Observation Status, and verify a used Observation Status cannot be deleted.
  • Audit_Reasons_Admin.doc: Reviews the “Modify System Attributes – Audit Reasons” option in the PKS. Demonstrates the user’s ability to modify existing “Audit Reasons”, create new Audit Reasons, delete unused Audit Reasons, and verify a used Audit Reasons cannot be deleted.
  • Manage_Units_Admin.doc: Reviews the “Modify System Attributes – Manage Units (Unit Category, Edit Unit, and Conversion Factor)” in the PKS. Demonstrates that a PKS Admin user can add a new Unit Category, add a new Unit to a Unit Category, add a new Conversion Factor, delete a Conversion Factor, delete a Unit, and delete a Unit Category that does not have any associated Units.
  • ResetPassword_Admin.doc: Demonstrates that a PKS Admin user can reset a password for a user.
  • Archive-Restore_Admin.doc: Demonstrates that a PKS Admin user can archive a study to another PKS schema, and can restore an archived study back to the original PKS schema.
  • View_Jobs_Admin.doc: Demonstrates that a PKS user is able to monitor submitted processes using the ‘View Jobs’ dialog. This user will monitor the status changing from ‘submitted’ to ‘complete’.
  • Delete_Study_Admin.doc:Demonstrates the user’s (Admin) ability to delete studies within the PKS. The Delete Study feature will remove all Study related information from PKS.

Other

  • Filter_Options.doc:Demonstrates how the dialog Filter Options can narrow query returns by using filter options. The Filter Options work similarly throughout the PKS Web Admin and can be found on many of the PKS menu items.
  • Password_Expiration_Verification-DBA.doc Demonstrates the Password Expiration settings and how those settings affect an Oracle profile and user accounts. The Oracle DBA will create a profile with one (1) day prior to expiration, to verify the password expiration messages from PKS and the client interfaces to PKS.

    The DBA will wait 24 hours to finish the test case in order to verify the password did expire.
  • Data_Migration_of_2.1_to_3.1 Demonstrates that the migration of a PKS 2.1 database instance to PKS 3.1 data instance leaves the study and scenario data unchanged and intact.
  • Data_Migration_of_3.0_to_3.1 Demonstrates that the migration of a PKS 3.0 database instance to PKS 3.1 data instance leaves the study and scenario data unchanged and intact.

PKS_Clean_Up

  • Clean_Up-DBA Removes all Validation attribute values in the PKS test database. The test case will verify all the validation studeis, scenarios, and queries have been removed, and the "Additional Data History Report" has logged the value of "Deleted" for all the validation attributes.