Quality Management - MES - Manufacturing Execution System Centra Softw

Quality Management

Quality should be managed not only at the final stage of production, but at every step of the process. The Quality Management Module digitizes all quality control processes from pre-production to shipment, allowing you to detect errors before they occur. It ensures product quality with automatic test plans, sampling processes and instant evaluations.

This module provides an infrastructure that is always ready for audits by working in full compliance with international standards such as GMP, ISO 9001, GLP and HACCP. Operational excellence is ensured and customer satisfaction is strengthened with nonconformity management, CAPA processes, calibration tracking and audit records.

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Quality Management

Plan quality tests, manage nonconformities, and audit product release processes. Ensure quality with calibration, trend analysis, and audit management; ensure full compliance with standards, and increase traceability.

Quality Control

Non-Conformance Management

Product Release

Calibration Management

Quality Reporting

Audit Management

Quality Control Planning

It ensures that the quality control tests to be applied during the production process are systematically planned and managed with automation. The aim is to ensure product quality and to carry out production in accordance with standardization.

Features

Quality Control Test Identification
Creating Test Protocols
Sampling Plan
Control Process Automation

Quality Control Test Definition
Appropriate tests are determined according to product group, production line and customer quality requirements. These tests can be physical, chemical or functional controls and are managed through the system.

Creating Test Protocols
The steps to be applied for each test, test parameters, acceptance/rejection criteria and limit values are defined in the system as standard protocols. This structure ensures the consistency of the test processes.

Sampling Plan
It is determined at which stages of production, how often and in what quantity samples will be taken. The sampling method (sampling type) is recorded in the system to ensure accuracy in analysis.

Control Process Automation
Quality control tests are initiated automatically at certain stages of production. Test results are recorded directly into the system without manual entry, providing traceability and speed.

Non-Conformance Management

It ensures that nonconformities detected during production are recorded, analyzed and resolved. The aim is to systematically address deviations in product quality and prevent recurrence.

Features

Non-compliance Record
Nonconformance Root Cause Analysis
Corrective and Preventive Action (CAPA) Planning
Tracking and Approval Process

Non-Conformance Record
Defective products, non-quality results or process deviations detected during the production process are recorded in detail through the system. These records form the basis for traceability and retrospective analysis.

Nonconformity Root Cause Analysis
The sources of recorded nonconformities are analyzed to determine their root causes. This analysis plays a critical role in identifying and eliminating systematic problems in production processes.

Corrective and Preventive Action (CAPA) Planning
Corrective and preventive activities are planned to prevent the nonconformity from occurring again. These activities are assigned to the relevant personnel, responsibilities are clarified and monitored through the system.

Monitoring and Approval Process
The effectiveness and implementation status of planned activities are monitored through the system. Successfully completed actions are approved and the nonconformance process is closed and archived in the system.

Product Release and Approval

It ensures that post-production quality controls are completed and products are approved for release to the market. The aim is to ensure customer satisfaction and legal compliance by ensuring that only products that meet quality criteria are released.

Features

Production Batch Control
Results Evaluation
Approval and Release
Recording and Reporting

Production Batch Control
After the production process is completed, the determined batch samples are subjected to quality control tests. These tests aim to verify the physical, chemical or functional properties of the product.

Result Evaluation
Test results are analyzed through the system to check whether the products comply with the defined quality criteria. In case of non-compliance, the product is rejected and not included in the process.

Approval and Release
Products that have successfully passed quality controls are approved through the system by authorized personnel. Approved products are released and included in the distribution process.

Recording and Reporting
All quality control and release processes are recorded in the system. These records are archived for use in audits and to ensure traceability.

Calibration and Equipment Verification

It ensures that regular calibration and verification processes are managed to ensure the accuracy and reliability of the devices used in quality control processes. The aim is to ensure the validity of test results by minimizing measurement uncertainty.

Features

Equipment Identification
Calibration Planning
Automatic Reminders and Alerts
Calibration Recording and Reporting

Equipment Identification
All devices and equipment used in quality control are recorded in the system with information such as brand, model, serial number and purpose of use. This facilitates traceability and tracking.

Calibration Planning
Appropriate calibration intervals are determined for each device and an annual or periodic calendar is created on the system. This planning ensures that the devices are kept under regular control.

Automatic Reminders and Warnings
When the calibration time approaches, the system automatically sends notifications to authorized personnel. Delays are prevented and processes are ensured to continue uninterrupted.

Calibration Recording and Reporting
The calibration operations are recorded in the system with their details. The accuracy data obtained after calibration is analyzed and the conformity status of the device is reported.

Quality Reporting and Trend Analysis

It enables systematic analysis of data obtained from quality control processes and monitoring of quality performance over time. The aim is to support continuous improvement and quality assurance processes.

Features

Quality Performance Reports
Trend and Deviation Analysis
Improvement Suggestions
KPI (Key Performance Indicators) Reporting

Quality Performance Reports
All quality control tests performed during production processes are analyzed in the system and detailed performance reports are created for each product or production batch.

Trend and Deviation Analysis
Quality data is evaluated over time to identify non-standard deviations. These analyses help identify root causes that lead to quality declines.

Improvement Suggestions
Process improvement and efficiency suggestions are developed to increase quality in line with the findings obtained. These suggestions are converted into action plans in the system.

KPI (Key Performance Indicators) Reporting
Critical indicators of quality such as nonconformance rate, rejection rate, customer complaints and rework needs are analyzed and presented to management. These indicators are used in strategic decision support processes.

Audit and Compliance Management

It enables the evaluation of quality systems through internal and external audits and full compliance with regulatory requirements. The aim is to ensure the continuous development and auditability of the quality system.

Features

Audit Planning
Audit Checklist
Reporting of Audit Results
Monitoring Corrective Actions

Audit Planning
Annual or periodic plans are prepared for internal audits, customer audits and official institution audits. The audit calendar is managed through the system and notifications are sent to the relevant units.

Audit Checklist
Checklists are created for the process steps, documents, procedures and physical controls to be examined within the scope of the audit. These lists ensure that audits are carried out systematically.

Reporting of Audit Results
Findings, deficiencies, strengths and improvement opportunities obtained during audits are reported in detail. The reports are presented to the management and the quality system performance is evaluated.

Corrective Actions Monitoring
Corrective actions are planned for nonconformities detected during the audit. The implementation and completion status of these activities are monitored through the system to ensure compliance.