Fundamental Concepts
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Laboratory Concepts: Stability |
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Fundamental Concepts |
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| Laboratory Concept | LabVantage Concept | Example | |||||||||||||||
| Stability Study | The purpose of Stability Study is to provide evidence on how the quality of a product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. It also allows to establish a retest period or a shelf-life for a product and recommended storage conditions. | ||||||||||||||||
| Stability Study Setup | A Stability Study is a mechanism
for executing one or more Stability Plans. The purpose of a Stability
Plan is to organize Tasks at specified time points, based on conditions.
A stability plan can be created from a template, a protocol or a study.
A Plan lets you define the conditions under which samples are stored during
testing, as well as the time points (intervals) at which to perform the
tests. It defines a set of events that will occur at specific times, for
each environmental condition, for each of the study units. The primary purpose
of a stability plan is to execute the pre-specified tasks (e.g., pull sample
for each time point and/or specified condition). A Grace Period
can be optionally defined for Task completion. If the Grace Period is violated
an Incident can be reported.
A Stability Study applies to only one Product. Since a Study applies to only one Product, all Plans for that Product will be executed by the Study. Most often, a Study is based on a Protocol. A Protocol is usually associated with one or more Stability Plans for one or more Products included in the study. You can also add Stability Plans directly to a Study without associating it with any Protocol. If a Plan is added to a Study (without Protocol), then based on the Container selected, the inventory is auto-calculated and displayed in the Initial Quantity, Future Quantity Required and Storage & Quantities fields. After a Study is initiated, an internal mechanism called the Event Scheduler will manage all tasks for all conditions in all plans in the Study. These are called Scheduled Events. Each Scheduled Event defines the execution of a Task at a Time Point. When each Time Point arrives, another internal mechanism called the Task Executor executes each Task. A Study Event Calendar is also available within the system that shows historical and prospective information regarding Tasks. Choose to view the Calendar by a particular Study, all Studies, Study Suites, Department or Owner. |
A Stability Plan may define that following
start of a study, three Pull Sample Tasks are to be executed on three consecutive
days for a single Condition (e.g., 25C/50% RH). Although this is a single
Plan, often studies are executed with multiple Plans [e.g., Pull Sample
Tasks on 3 consecutive days for two separate conditions (25C/50% RH and
40C/75% RH)].
I do not need to Request a Study for Approval. I create the Study "ST100" from Protocol "P1". "Plan A" defines the tasks to be executed. I need to determine at what temperature "Product A" can be stored before becoming compromised. I plan to store "Product A" in both a Cold and Hot environment, and test the product every hour, for 4 hours. To set up this Study I define "Plan A" which includes the following:
I create Protocol "P1" and include the Product/Plan combination of "Product A" and "Plan A". LabVantage determines, based on the number of time points and the quantities defined in the Advanced Pull Sample task, that I need 4 (per condition) containers of "Product A" to complete all the testing. |
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| Create a Study | A Study Request is the process
of creating a new Study that must be submitted for review and approved before
it can become an active "Study" within the system for execution. An authorized
person is responsible for approving a Study request. Optionally, define
a Study Request as you would an actual Study then submit for Approvals.
If Approved, it becomes a New Study. An authorized person can then work
with the Study while it is Active.
The Study executes the testing plan as defined by the associated Plans and Protocols. In the Study, define start dates for each Condition and if necessary make any changes to the Plan. Once defined, you can "Request Running" for each Condition individually. See Start Study below for more information. |
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| Group Similar Studies | A Study Suite is a LabVantage
concept and is a collection of multiple Stability Studies called "Members".
You can work with the Member Studies from within the Study Suite. An individual
Member Study can belong to only one Study Suite.
Study Suites are useful for studies sharing common tests, time points or conditions, where different products are managed together, and where a single protocol is used for all studies created within a Study Suite. |
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| Start and Manage Studies | For each Condition within a Stability Plan,
you can specify a Start Date and other requirements necessary for the Condition
to start. When you "start a Study", it means that all Conditions for all
Plans that meet the start requirements will start. You can also change any
Study Plan Condition Status. This affects the Study in accordance with the
Status Rules. All Status changes on an Active Study require approval.
Studies are organized by Condition. Each Condition details the time points, tasks that determine sampling and testing, and any Workorders to identify procedural requirements. Before testing can begin the Plan Condition must be Started with an Approval. A Study starts when at least one condition has been approved to start. It is then considered "Running". Once Running, as the time points arrive, any associated Tasks or Workorders are triggered. Should you need to make changes to a Running Study it can be Suspended, then approved again before restarting. An audit trail provides the history of changes. Studies can be deemed Complete or Cancelled at any time. You have the option to automatically complete a Study or disable auto completion. To automatically complete a Study a task must be defined with an action that governs the auto-completion of Study. The study is completed when the defined pre-requisites are fulfilled. Separately, you also have the option to manually complete a Study. Any unplanned deviation or a planned modification in a Study can be recorded, and is handled by the Lab Investigations module. |
I define a Start Date of 4/15 at 12:00 pm and
request that the Study start "Running". The Study is approved on 4/14 at
12:00. At 12:00 on the 15th the first Samples are added for each
condition. Testing must be completed within 15 minutes. At 1:00 the second
Samples are created and so on until 4:00 when the last Samples are created.
The Study is considered complete when all the Conditions are complete.
While the Study is "Running" I can view progress. When I look at the Calendar for 4/15 I will see (depending on the time) which tasks are done and which are still to be completed. |
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| Calculate Sample Quantities | Inventory Calculation determines the number of Product Containers required for each Condition. LabVantage considers the number of time points, quantities required for each test, and any other factors, such as repeats or whether or not a partial pull is allowed. | Assume we are testing a Product that is stored in 100 ml bottles. We only need 10ml per test at each of the 4 time points, no repeats. If a partial pull is allowed we only need 1 bottle, otherwise we need 4. | |||||||||||||||
| Perform Stability Analytics | Optionally, NWA Quality
Analyst can be included to provide a comprehensive, integrated set of
Statistical Quality Control (SQC), charting and analysis functions.
You can perform several types of statistical analyses on your data such as One-way ANCOVA, and Regression Analysis. |