Method and Protocol Management

This component aims to define the methods and application protocols used in laboratory analyses, to track versions, and to ensure methodological consistency across all analyses. This ensures standardization in testing processes, minimizes errors, and strengthens quality management.

Features

•  Method Definition
•  Establishing Protocol Standards
•  Revision and Update Management
•  Protocol Approval Process

Method Definition
The analysis methods used in the laboratory (such as HPLC, GC-MS, UV-Vis) are defined in detail in the system and recorded. These methods are selected based on analysis and are taken as a reference to be used throughout the process.

Defining Protocol Standards
Application steps, device settings, reagents used and chemical dosage information for each analysis are standardized on the system. In this way, it is guaranteed that different personnel apply the same procedure in the same analysis.

Revision and Update Management
Every change made to methods and protocols is recorded in the system with the version number. Old and new versions are made comparable and change history is preserved for traceability.

Protocol Approval Process
Newly created or updated methods and protocols are submitted to authorized persons for approval through the system. Approved protocols come into force, while those not yet approved are rendered unusable during the analysis process.

Work Order Management

This component allows the creation of work orders on the system for analysis processes to be carried out in the laboratory, their assignment to responsible persons and the step-by-step monitoring of processes. The balanced distribution of workload, tracking of tasks and their timely completion are digitally controlled through this component.

Features

•  Defining a Work Order
•  Appointment of Responsible Personnel
•  Progress Tracking
•  Automatic Notifications and Reminders

Work Order Definition
Analyses planned to be performed for samples accepted to the laboratory are defined as work orders on the system. Each work order includes specific analysis steps and is associated with the sample, ensuring that the processes are carried out in a planned manner.

Assigning Responsible Personnel
Each work order created is assigned to the relevant laboratory personnel or department responsible for the analysis. With this assignment, task responsibility becomes clear and ownership of the process can be tracked digitally.

Progress Tracking
The status of work orders can be monitored instantly through the system. The status of each work order, such as pending, in process or completed, is updated by the system, making the management of the entire process transparent.

Automatic Notifications and Reminders
When the work order deadline approaches, the system supports time management by sending automatic notifications to the responsible personnel. This feature prevents delays and ensures the uninterrupted progress of the analysis process.

Analysis Data Recording and Results Reporting

This component ensures that all data obtained during laboratory analyses are recorded systematically and presented to relevant persons by turning these data into meaningful reports. While the accuracy and consistency of the data are controlled, decision-making processes based on analysis results are accelerated and traceability is increased.

Features

•  Data Entry and Recording
•  Results Evaluation
•  Preparation of Analysis Reports
•  Automatic Deviation Notification

Data Entry and Recording
All measurement values, tolerance ranges and observations obtained during the analysis process are recorded on the system. These data constitute a reliable source for both instant monitoring and retrospective analysis.

Result Evaluation
The collected data is compared with predefined criteria to evaluate the accuracy and validity of the analysis. Thanks to this comparison, erroneous results can be detected early and the process can be intervened.

Preparation of Analysis Reports
The results of the analyses performed are presented by the system in the form of detailed reports specific to the user or department. Reports can be prepared both visually and textually and exported in the required format.

Automatic Deviation Notification
When analysis results fall outside the specified threshold values, a deviation notification is automatically generated by the system. These notifications are directed to the relevant personnel, allowing rapid action to be taken.

Corrective and Preventive Action (CAPA)

This component ensures the systematic detection of nonconformities occurring in the analysis processes, the planning of corrective and preventive activities against these nonconformities, and the verification of the effectiveness of these activities by monitoring. Thus, continuous improvement of laboratory processes and quality assurance are ensured.

Features

•  Non-conformity Detection
•  Corrective Action Planning
•  Monitoring and Verification
•  Auditing and Reporting

Non-Conformity Detection
If the analysis results are outside the specified standard values, the system automatically creates a non-conformity record. This record initiates the process for detailed evaluation by the quality units.

Corrective Action Planning
A corrective action plan is prepared through the system for the detected nonconformities. Responsible persons are assigned within the scope of the plan and the process is initiated by defining the necessary steps.

Monitoring and Verification
The process of carrying out corrective actions is monitored step by step on the system. When the activity is completed, the effectiveness of the actions taken is evaluated and the verification process is carried out and recorded.

Audit and Reporting
All CAPA records are reported in detail in the system and archived to be presented in audits. Thanks to these reports, transparency and traceability of quality processes are increased.