Sample and Storage Conditions Management Module

Sample and Storage Conditions Management Module digitally manages the acceptance, storage and shelf life controls of samples to be used in stability analyses. It ensures that sample processes are carried out in a traceable and controlled manner, and provides an early warning mechanism by detecting deviations in storage conditions.

Features

•   Sample Acceptance and Registration
•   Storage Condition Monitoring
•   Shelf Life Management
•   Sample Tracking System
•   Condition Deviation Notification
•   Stock Management

Sample Acceptance and Recording
Ensures that samples taken for stability testing are recorded completely in a digital environment. Critical information such as sample name, lot number, production date and test plan are recorded and tracked.

Storage Condition Monitoring
ensures that samples are stored in accordance with environmental factors such as storage temperature, humidity and light. When there is a deviation in conditions, the system automatically sends a warning to the relevant teams.

Shelf Life Management
Monitors the periodic analysis of samples according to the determined stability test dates. The system creates advance notifications for samples approaching their shelf life, preventing disruption of the process.

Sample Tracking System
provides traceability by recording in detail which sample has gone through which analysis processes. Thus, the history of the tested samples can be easily tracked through the system.

Condition Deviation Notification
The system generates instant notifications when temperature, humidity or light changes occur in the environment where samples are stored. In this way, situations that jeopardize the reliability of stability analyses are detected early.

Stock Management
Tracks sample stock levels and creates automatic order suggestions for samples that are depleted or have fallen to critical levels. Thus, there is no delay in analysis processes due to sample shortages.

Analysis Methods and Test Management Module

Analysis Methods and Test Management Module enables the definition, approval and management of analysis processes of test methods used in stability analyses. It enables all test processes to be carried out in a standardized, traceable and reliable manner.

Features

•   Defining Test Methods
•   Method Approval Process
•   Parameter Monitoring
•   Test Delay Notifications
•   Recording Test Results
•   Deviation Detection and Warning

Test Methods Definition
Test methods to be used in stability analyses are defined on the system with detailed parameters. For each method, standard test processes are created by recording information such as temperature, time, device and chemical used in the system.

Method Approval Process
Newly defined test methods are not used without being reviewed and approved by the quality team. Revisions are recorded in the system to ensure traceability and prevent non-standard analyses.

Parameter Monitoring
Critical parameters such as temperature, pH, humidity, and pressure that need to be monitored during analysis are defined in the system. In case of deviations in these values, personnel are informed with automatic warnings.

Test Delay Notifications
The system monitors whether the planned analyses are performed on time. In case of delay, the system automatically sends a warning notification to the responsible persons.

Recording of Test Results
Analysis results are automatically obtained from the test devices and recorded digitally in the system. In this way, manual entry errors are prevented and the accuracy of analysis results is increased.

Deviation Detection and Warning
The analysis results obtained are compared with predefined threshold values ​​in the system. When the value is exceeded, an automatic deviation notification is created and processed into the relevant reports.

Results Evaluation and Trend Analysis Management

The Result Evaluation and Trend Analysis Module enables the evaluation of data obtained from stability analyses, the analysis of long-term changes and the creation of trend reports. It helps predict product stability and allows the identification of possible quality risks in advance.

Features

•   Results Comparison
•   Trend Analysis
•   Deviation and Risk Reports
•   Data Visualization
•   Automatic Reporting
•   Non-Conformance Management

Results Comparison
Compares the analysis results of the same product in different time periods. By evaluating the obtained data, it detects changes over time and determines deviations.

Trend Analysis
Provides insights into product durability by analyzing changes in stability test results. It enables the early detection of potential quality problems by evaluating long-term trends.

Deviation and Risk Reports
Informs quality teams by creating risk reports in case the determined critical threshold values ​​are exceeded. It ensures rapid intervention in nonconformities with suggested actions.

Data Visualization
Presents analysis results in graphical and tabular formats, making trends more understandable. It helps users interpret data easily.

Automatic Reporting
Creates automatic reports according to specified analysis periods and forwards them to relevant teams. In this way, quality processes can be monitored without interruption.

Non-Conformity Management
Automatically creates a "Non-Conformity Notification" when analysis results fall outside the specified limit values. Thus, it accelerates the action taken in quality processes.

Reporting and Certification Module

The Reporting and Certification Module ensures that data obtained from stability analyses are presented in regular and standardized reports. It provides complete information during audits by managing certification processes in accordance with GLP, GMP and ICH standards.

Features

•   Report Templates
•   Certification Management
•   Digital Archiving

Report Templates
Allows analysis results to be prepared in specified formats and presented with customizable templates according to different needs. Creates easily accessible reports for audits and internal controls.

Certification Management
If the analysis results are found appropriate, it automatically creates a "Stability Conformity Certificate". In this way, quality processes are accelerated and verification documents are secured.

Digital Archiving
Stores all analysis results and certificates securely in a digital environment. Provides quick turnaround in audits by providing easy access to authorized users.

Warning and Notification Management Module

The Warning and Notification Management Module instantly detects any delays, errors, and nonconformities that may occur in stability analyses and automatically sends notifications to responsible persons. In this way, processes are managed without interruption and quality control processes are secured.

Features

•   Test Delay Warnings
•   Condition Deviation Notifications
•   Sample Shelf Life Notifications
•   Critical Process Notifications
•   Non-Conformance Detection Alerts
•   Periodic Reminders

Test Delay Alerts
Creates automatic notifications when there are delays in planned analysis processes. Prevents unplanned disruptions by reminding the analysis team to follow up on the process.

Condition Deviation Notifications
When there are temperature, humidity or light changes in the storage conditions of the samples, the system automatically informs the relevant units. In this way, analysis reliability is maintained.

Sample Shelf Life Notifications
Provides advance warning for samples that are about to expire, ensuring that testing processes are completed on time. It prevents delays and streamlines stability analyses.

Critical Process Notifications
The system automatically sends notifications when critical limits defined in production areas are exceeded. It supports rapid action to ensure compliance with GMP and quality standards.

Nonconformity Detection Alerts
Automatically sends alerts to the quality team and managers when analysis results fall outside the specified limit values. Provides early detection of possible product errors.

Periodic Reminders
Prevents disruption of processes by providing timely reminders for planned analyses, calibration, maintenance and periodic tests. Notifications are sent to users via in-system notifications or e-mail.