Corrective and Preventive Action (CAPA) 

It ensures that corrective and preventive activities are systematically planned, executed and reported by going to the root causes of nonconformities detected in laboratory processes to prevent similar errors from recurring. It plays a critical role in continuous improvement of processes and quality assurance.

Features

•   Creating a CAPA Request
•   Activity Planning
•   Implementation and Tracking
•   Results Evaluation and Reporting

Creating a CAPA Request
Corrective or preventive action suggestions are created through the system in line with the detected nonconformities. These requests are recorded and submitted to the evaluation of the relevant units.

Activity Planning
Responsible persons are determined in line with the approved CAPA requests and the implementation period for each activity is defined. This planning ensures that the process is managed in a timely and traceable manner.

Implementation and Follow-up
The implementation status of the determined activities is monitored step by step through the system. Each completed transaction is processed into the system, creating a transparent monitoring mechanism.

Results Evaluation and Reporting
After the completion of the activities, the effectiveness of the actions taken is evaluated. The results are reported according to the impact analysis and archived for use in both audits and internal quality controls.

Internal Audit and Compliance Management 

It ensures that the internal audit processes carried out to ensure compliance of laboratory activities with quality standards (ISO, GLP, FDA etc.) are managed in a planned, systematic and traceable manner. Continuous improvement is ensured in line with the findings detected, and the laboratory's compliance with regulations is ensured.

Features

•   Audit Planning
•   Audit Checklists
•   Audit Findings Record
•   Audit Reporting

Audit Planning
Annual or periodic audit schedule is created in the system in accordance with relevant quality standards (e.g. ISO 17025, GLP, FDA). Thanks to this planning, all audits are carried out regularly and on time.

Audit Checklists
The headings, questions, parameters and process steps to be checked during the audit process are defined in advance on the system. This ensures that audits are carried out in a standard and complete manner.

Audit Findings Record
Deficiencies, nonconformities or areas requiring improvement identified during the audit are recorded in detail through the system. Each finding is assigned to the relevant process or unit and made traceable.

Audit Reporting
The results of the audit performed are reported by the system and presented to the management. These reports determine the actions to be taken and support quality management processes.

Training and Competency Management 

It ensures that the technical knowledge, skills and competence levels of laboratory personnel are monitored; that necessary training is planned and deficient areas are completed. With training monitoring and competence analysis, task distribution is made consciously, compliance with regulations is increased and quality assurance is supported.

Features

•   Staff Training Records
•   Compulsory Education Planning
•   Education Evaluation
•   Competency Tracking and Reporting

Personnel Training Records
All training history, certificates received, seminar attendance and areas of expertise of employees are recorded in detail in the system. These records are used as a reference in personnel job assignments.

Mandatory Training Planning
Mandatory training on certain analysis techniques, laboratory safety or equipment usage is planned through the system. The participation process is initiated by sending an automatic notification to the relevant personnel.

Training Evaluation
The success of the participants is measured through evaluations made at the end of the training. Personnel who successfully complete the training are marked in the system and included in the competency list.

Competency Tracking and Reporting
Each employee's competency status is reported in a traceable manner through the system. Automatic planning is made for missing or renewed trainings and regular information is provided to the management.

Quality Reporting and Monitoring 

This component ensures that all data related to the laboratory's quality management processes are analyzed and these analyses are presented in comprehensive reports. Quality assurance processes are managed sustainably by systematically monitoring nonconformities, audits and improvement opportunities.

Features

•   Quality Performance Reports
•   Trend and Improvement Reports
•   Audit and Compliance Reports
•   Data Access and Authorization Control

Quality Performance Reports
Nonconformity records recorded in the system, CAPA activity progress and audit findings are analyzed regularly. In light of this data, quality performance is reported in detail.

Trend and Improvement Reports
Changes in quality processes at certain periods are evaluated with graphics and statistical analysis. In this way, weak points are determined and areas for improvement are revealed.

Audit and Compliance Reports
Detailed reports covering all quality processes are created for use in internal and external audits. These reports are used to document the laboratory's compliance with regulations and quality standards.

Data Access and Authorization Control
Quality reports can only be viewed by authorized users. Access authorizations are defined through the system to ensure information security and data confidentiality.

The effectiveness of the systems is constantly checked.