Introduction

This section describes how to use the LabHQ Stability Study Management Module effectively to create Stability Studies and monitor time points for testing.

Setup

Study Templates

Study Templates are used to create Stability Studies. Study Templates can be accessed from Stability > Set-up > Study Templates. On selecting the page, a list of Study Templates configured in the system will display in the left hand pane, and the Details tab will be displayed in the content area (See Figure 1 below). There are four tabs at the top of the page: All, Draft, Approved, and Retired. Selecting these tabs will filter the list of Study Templates in the left hand pane.

Figure 1: Study Templates

Figure 1: Study Templates

 

How to add a new Study Template
Select the ‘+’ button next to the search bar in the left-hand pane. A pop-up will appear for the user to enter a Study Template name. The name must be unique, and therefore an error message will appear if the user tries to create a new Study Template with the same name as an existing Study Template.

Study Template Details
The Details tab displays the following fields for the user to configure:

Name – The name of the Study Template is editable and will appear as entered in the pop-up.

Products – A list of products configured in main LIMS.

Workflow – A list of workflows configured for the product selected above.

Description – A free text field for the user to enter a description of the Study Template.

No of Units – A numerical field to enter the number of units required for the Stability Study. The user can also define the units from a list populated by the Common Units phrase list.

Contingency – A numerical field to enter the number of units required for contingency.

Total Number of Units – This field will calculate the No of Units plus contingency to provide a total number of units for the Stability Study.

Condition – This section is populated by the Stability Conditions phrase list. The default values provided are 25°C/60%RH, 30°C/65%RH, 30°C/75%RH, and 40°C/75%RH. A sub-tab for each condition ticked will appear in the Time Points tab.

Approved – This is a tick box only available to users with ‘Approve Study Templates’ permission. When the user ticks this box and selects save, the Study Template becomes available for use within the module.

Study Template Time Points

A sub-tab for each selected condition on the Details tab will appear in the Time Points tab (See Figure 2 below).

Figure 2: Study Template Time Points

Figure 2: Study Template Time Points

For each condition the user can configure the following fields:

Name – A unique name can be given for each time point in this condition.

Time point – A drop-down list for the user to select the time point. The values available are as follows: Initial, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months and 48 months.

Interval – A numeric field to enter the number of days from the study start date at which the time point is due.

Date Window – A numeric field for the user to enter the number of days -/+ the due date for the time point. The date window is used for notifying users when a time point is due.

Watch Lists

Watch Lists are used to monitor batches of product submitted for testing in Main LIMS so that the user can decide if a Stability Study should be created from the same batch. Watch Lists can be accessed from Stability > Set-up > Watch Lists. On selecting the page, a list of Watch Lists configured in the system will display in the left-hand pane, and the Watch Lists tab will be displayed in the content area (See Figure 3 below). There are four tabs at the top of the page: All, Draft, Approved and Retired. Selecting these tabs will filter the list of Watch Lists in the left-hand pane.

 

How to add a new Watch List
Select the ‘+’ button next to the search bar in the left-hand pane. A pop-up will appear for the user to enter a Watch List name. The name must be unique, and therefore an error message will appear if the user tries to create a new Watch List with the same name as an existing Watch List. The user can configure the following for a Watch List:

Active Between – A date range from which the Watch List will monitor main LIMS Study creation.

Name – A drop-down list of products configured in main LIMS.

Description – A free text field for the user to enter a description.

Planned – The number of Stability Studies planned for the selected product.

Started – A calculated field that increments each time the user confirms to remove the product from the watch list when a stability study is created for the product.

Remaining – A calculated field subtracting the number started from the number planned.

Remove Removes a row from the Watch List

Add Adds a row to the Watch List

Approved – This is a tick box only available to users with ‘Approve Watch List’ permission. When the user ticks this box and selects save, the Watch List becomes available for use within the module.

Import Products – Selecting this button automatically populates the Watch List with a row for each product where the product is configured with a stability sample.

Create Study

The first step in a Stability Study lifecycle is Create Study. This allows the user to enter the details to start a Stability Study from a Study Template. LabHQ will use this Stability Study to monitor due dates for time points and for submission of samples to main LIMS for testing. The user can access the page by selecting Stability > Create Study. On selecting the page, a list of Stability Studies created in the system will display in the left-hand pane, and the Details tab will be displayed in the content area (See Figure 4 below). There are seven tabs at the top of the page: All, Draft, Approved, Live, Completed, Stopped and Retired. Selecting these tabs will filter the list of Stability Studies in the left-hand pane.

Figure 4: Create Study

Figure 4: Create Study

 

How to create a new Stability Study
Select the ‘+’ button next to the search bar in the left-hand pane. A pop-up will appear for the user to enter the Stability Study name. The name must be unique, and therefore an error message will appear if the user tries to create a new Stability Study with the same name as an existing Stability Study. The user must also select a template from the drop-down menu. The list of templates are approved Study Templates configured in the system. After confirming the name and template, the details from the Study Template will populate the fields automatically. The following fields are then available for the user to enter data:

Client – A list of clients configured for the selected product.

Batch No – An alpha-numeric field for the user to enter the product’s batch number.

Description – A free text field for the user to enter a description for the Stability Study.

Start Date – A date field that automatically populates with Today’s date. The due date for each time point is calculated from this date.

Date of Manufacture – A date field that automatically populates with Today’s date.

Approved – This is a tick box only available to users with ‘Approve Stability Studies’ permission. When the user ticks this box and selects save, the user is requested to enter their electronic signature. The Stability Study will then become available to initiate within the module.

Stop Study – Where a Stability Study has been initiated, the user has the ability to stop the Study. When the user selects this button, the user is requested to enter their electronic signature. The system will then stop monitoring the due dates for time points within the Stability Study.

Initiate – After the Stability Study is marked approved, the Initiate button becomes active. When the user selects Initiate, the system will start monitoring the due dates for time points and notify users accordingly.

Time points – The following fields are editable within the Time Points tab on a Stability Study:

Date – The date will automatically calculate using the start date plus the interval. The user can modify this date where appropriate (See Figure 5 below).

 

Figure 5: Create Study Time Points

Figure 5: Create Study Time Points

 

Additional Fields – Where configured on the Study Template, the additional fields will appear as columns within each condition so the user can record data for each time point.

 

View for information on Notes.

View Studies

The View Studies page displays an overview of Stability Studies in the system (See Figure 6 below).

Figure 6: View Studies

Figure 6: View Studies

 

The View can be filtered by the following:

Select Client – A drop-down list of Clients that have Stability Studies initiated.

Date From/To – The user can select the date range which will filter based on the start date of a Stability Study.

Search – A type search field that searches on all fields in the table.

The following information is displayed in the table:

Study ID – A unique sequential ID generated by LabHQ.

Edit – Displays further details of the Stability Study in a right-hand pane. The data fields are – Study ID, Name, Product, Client, Batch Number, Number of Units, Start Date, Contingency, and Total Number of Units.

Status – The current status of the Stability Study.

Name

Product

Batch Number

Start Date

Summary – When the user highlights a Stability Study, the Summary button becomes active. This produces a report as a pdf. The default report displays a table of test results grouped by condition for the selected Stability Study.

If the user double clicks on a Stability Study, a nested table appears with the following information:
– Condition
– Time Point
– Pull Date
– Number to Pull
– Number Pulled
– LIMS Study Status – the sample status in Main LIMS

View Schedule

The View Schedule page displays an overview of Stability Study time points due in the system (See Figure 7 below).

Figure 7: View Schedule

Figure 7: View Schedule

 

The View can be filtered by the following:

Pull Date From/To – The user can select the date range which will filter based on time point due date (i.e. pull date).

Search – A type search field that searches on all fields in the table.

The following information is displayed in the table:

– Status

– Stability study ID
– Stability Study Name
– Description
– Batch Number
– Product Name
– Product Description
– Condition
– Time Point Name
– Time Point
– Pull Date
– Number To Pull
– Number Pulled

Pull Units

Pull Units is used to create Main LIMS Studies to test stability samples for a time point and condition. Pull Units can be accessed from Stability > Pull Units. On selecting the page, a list of live Stability Studies will display in the left hand pane, and the details for pulling samples will be displayed in the content area (See Figure 8 below).

Figure 8: Pull Units

Figure 8: Pull Units

 

The following information is displayed for information only:

– Study ID
– Study Name
– Product
– Batch
– Client

The following information can be entered by the user to effectively pull samples:

Condition – A drop-down list of conditions configured for the Stability Study.

Time Point – A drop-down list of time points configured for the Stability Study. The text for a time point will be:

Black – Where no samples have been pulled
Yellow – Where some samples have been pulled
Green – Where all samples have been pulled for that time point

Number of Units Required – A read-only field that will display the number of units required to pull as configured for the selected condition and time point for the Stability Study.

Number of Units to Pull – A numeric field for the user to record the actual number of units pulled.

Comments – A free text field for the user to enter any further information. When the user selects pull, a confirmation pop-up is displayed with the Main LIMS sample IDs. The samples will then be available at Create Work in Main LIMS for the user to progress for testing.