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Webinars Simploud’s monitoring system makes sure storage locations meet strict quality standards. By closely tracking environmental conditions and inventory, Simploud helps users keep materials in top condition from procurement or production all the way to final use. This process ensures that storage and handling follow industry regulations, boosting efficiency and protecting product integrity throughout its lifecycle.
Simploud uses two key records to maintain storage quality: Storage Location and Monitoring.
Monitoring Management Process
1
Storage Location Record Setup
The process begins with setting up detailed records for each storage location. This process begins with creating a new record for each storage location, which includes entering the location’s identification, type, environmental conditions, and layout. This setup is essential to ensure the storage location is ready to maintain material integrity.
2
Monitoring
Once the storage location is set up, continuous monitoring ensures optimal environmental conditions and inventory status. This stage involves tracking temperature, humidity, and other factors and regularly verifying the condition of stored materials.
Storage Location Record Setup
Step 1 - Create a New Storage Record
This step involves establishing the essential details for a storage location by creating a new record.
It includes entering key information such as identification, type, and relevant environmental conditions to ensure the area is prepared for use. Simploud provides two ways to create storage records: from the home page or the material units record.
Creation from home page
Creation from material units
Fill in the mandatory fields:
- Name: The “Name” field is essential for identifying the storage location within the system. It should be a unique and descriptive name that differentiates this location from others.
- Type: The “Type” field specifies the kind of storage area being created, such as a building, room, refrigerator, or other.
- GMP/Non GMP: This field indicates whether the storage location complies with Good Manufacturing Practice (GMP) standards. It is crucial for regulatory compliance and ensuring the storage area meets required quality standards.
- Storage Temperature: This field specifies the temperature range at which the storage location is maintained, such as room temperature (RT) or specific temperature turns.
- Number of Rows: This field determines the number of rows available in the storage location. It helps organize the storage space and ensures that materials can be ordered.
- Number of Columns: Similar to the “Number of Rows,” this field specifies the number of columns within the storage location. It aids in defining the layout of the storage area.
Step 2 - Define Sample Points
In this step, you specify the sample points within the storage location, which are essential for monitoring and quality control. These points represent a specific area where environmental monitoring occurs, tracking factors like temperature, humidity, or potential contamination to help maintain the quality of the stored items and ensure the environment is suitable for the materials stored.
1. Click on the plus button to add a new sample point.
2. Fill in the sample details.
- Sample Point ID: This is a unique identifier for the sample point, allowing it to be easily referenced and tracked within the system, ensuring that each sample point can be individually monitored and recorded.
- Type: This field specifies the type of sample being collected, such as “Surface Viable (SV).” The type determines the kind of monitoring or sampling that will take place at this point.
- Grade: The grade field indicates the cleanliness level or quality standard of the area being sampled. For example, “Grade A” might refer to a controlled cleanroom environment.
- Surface: This field identifies the specific surface where the sample will be taken, such as the floor, wall, or equipment. Specifying the surface helps pinpoint the exact location for monitoring.
- Sample Point Description: A description provides additional context or details about the sample point, such as its location within the storage area or any special considerations for sampling.
Step 3 - Define Storage Location
This final step involves configuring and managing the specific details of each storage location. It includes assigning storage positions, adding various items (e.g., materials, samples, or equipment), and monitoring the status of these items, such as whether they are in quarantine or stock.
This stage ensures that the layout, storage conditions, and storage area organization are finalized and optimized.
1. Navigate to the desired storage location and click on an available position within the storage location. A dropdown menu will appear.
2. If you select "Store Material Unit," Search for the material you want to store by typing its name or selecting it from the list. Once it is placed in the location, the status of the material (e.g., "Not stored yet") will be updated.
3. After assigning, the stored content will be listed under "Stored Content" with information like position, stored item, category, and status.
- Add Storage Location: You can create a nested storage location within the current one.
- Store Material Unit: Choose this option to store a specific material.
- Store Sample: Select this to store a sample in the chosen position.
- Store Equipment: Use this option if you need to store a piece of equipment in the designated position.
Monitoring Record Setup
Step 1 - Define Protocol Checklist
The protocol checklist is essential for guiding users through monitoring activities, ensuring that all steps are consistently followed and recorded. It uses a template object, where each protocol includes calculated results based on predefined conditions. When creating a new monitoring record, the protocol checklist is selected from existing templates designed to meet specific monitoring needs.
When setting up a new template for the protocol checklist, ensure the template type is set to ‘Monitoring’.
Step 2 - Create a New Monitoring Record
Creating a new monitoring record involves setting up all the necessary details to track and execute the monitoring activities effectively.
1. Click the Environmental Monitoring button to create a new monitoring record.
2. Enter monitoring information.
- Title: Enter a descriptive title for your monitoring activity.
- Type: Choose the appropriate monitoring type from the dropdown menu.
- Tested Location: Search for and select the specific location where the monitoring will take place. This step links the monitoring activity to the correct physical location within your facility. By linking the tested location to the monitoring record, the system organizes and tracks all related sample points within that location, ensuring that the monitoring process is thorough and properly aligned with the physical environment.
- Protocol Checklist: Choose a predefined protocol checklist from the available templates. The protocol checklist guides the monitoring process, ensuring all necessary steps are followed and results are calculated based on predefined conditions.
- Start Date and End Date: Enter the start and end dates for the monitoring activity.
- Incubation Settings: If your monitoring involves incubation, enter the start and end dates for the incubation period. If necessary, you can also select the specific incubator. These settings are critical for monitoring activities involving incubation, such as microbial sampling, where samples must be stored at exact temperatures.
Step 3 - Execution
The execution step ensures monitoring activities are carried out accurately and consistently. It enables reliable data collection and tracking of environmental conditions or sample points. Properly executing monitoring tasks ensures that deviations or potential issues are identified promptly, allowing for timely corrective actions.
To execute the monitoring, the sample point must be taken:
1. Click on the sample point in the Lab Information tab.
2. Click the edit button and mark the sample as taken.
After taking the sample and moving to the incubation stages, the execution table will change, allowing you to enter the details and check the result.
1. Click on the sample point in the Lab Information tab.
2. Insert the EM measurements, and click Save.
3. The result of the test will show on the table.
While reaching the completed stage, make sure to assign QC reviewers.
1. Click on the plus button.
