Audit and Reporting Management

The Audit and Reporting Management Module is a critical tool that ensures transparency of production and quality processes. This module ensures that all data is securely recorded in a digital environment and can be tracked with a time stamp. With the comprehensive reporting features provided by the system in both internal and external audits, businesses get faster and more efficient results in their audit processes.

In addition, the customized reporting tools provided by the module allow users to perform detailed analyses based on specific criteria. You can easily monitor all data from production errors to device usage and ensure full compliance with regulatory standards. Streamlining audit processes saves businesses time while also ensuring that regulatory requirements are met correctly.

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Audit and Reporting Management Module

The Audit and Reporting Management Module ensures that all records are accessible for auditing. Customized reports, visual analysis and easy archiving features ensure transparent and compliant reporting of processes.

Access to Records

Reporting Tools

Deviation Reports

Procedure Application

Record Access and Audit Tracking

All log records kept in the system are made accessible based on user, device, transaction and time. The audit trail mechanism is managed centrally in this module and provides transparency to audit processes.

Features

Filtered Search
Audit Trail Viewing
Monitoring Criteria
Authorized Access

Filtered Search
Records can be filtered by parameters such as date range, username or device ID. This feature allows you to quickly find a specific action or user activity.

Audit Trail Monitoring
System records all user actions with a time stamp. It is possible to track in detail which action was taken by whom and when.

Monitoring Criteria
Logs are used to log transactions such as entry, exit, approval, rejection, deletion, and editing. These records are critical for system security and monitoring user behavior.

Only users with specific authorizations can access the Authorized Access
Control screens. This is to protect the confidentiality of sensitive records and ensure the security of the audit process.

Customized Reporting Tools

Recorded data can be analyzed and printed using ready-made templates defined in the system or custom reports created by the user.

Solutions

Ready Report Templates
User Defined Reports
Bulk Data Extraction
Timestamp and Signature

Ready Report Templates
Predefined report templates are provided according to criteria such as process, equipment, personnel or incident type. In this way, fast, standard and consistent reporting can be done.

User Defined Reports
Users can create their own custom reports with field selection and filtering options. Reports can be exported in different formats (PDF, Excel, etc.).

Bulk Data Extraction
All logs belonging to specific batch numbers can be exported collectively. This feature is ideal for large volume data analysis and audit reporting.

Timestamp and Signature
Each report generated is archived with a timestamp and user identification information, documenting that the report is accurate and was produced by an authorized person.

Non-Conformance and Deviation Reports

All nonconformities, deviation entries and event records that occur during the process can be obtained as separate reports. These records can be used in integration with CAPA and quality management systems.

Features

Deviation Listing
Incident Details
CAPA Connection
Export

Deviation Listing
All deviation records can be filtered and listed. Users can search by criteria such as date, responsible person or event type and quickly view relevant deviations.

Incident Details
Detailed information is provided for each record, including description, response time, and responsible party. This makes tracking of deviations transparent and the process auditable.

CAPA Connection
Corrective and preventive actions (CAPA) initiated for deviations can be tracked through the system. With this connection, lessons learned from nonconformities can be systematically tracked.

Export
Deviation reports can be exported in Excel or PDF formats, allowing them to be easily shared with relevant units or archived.

Audit Preparation and Archiving

This component ensures that all e-log records are archived and stored ready for auditing. Digital records become securely accessible retrospectively.

Features

Archive Plan
Version Tracking
Creating an Audit Package
Secure Access Logs

Archive Plan
Defines how long and in what format records will be stored. This plan standardizes the archiving process to ensure legal compliance and preserve data integrity.

Version Tracking
Old versions of each e-log record are stored and kept accessible. This way, past changes can be easily analyzed and record integrity is maintained.

Audit Package Creation
All digital records for the requested audit period can be prepared as a single audit package (e.g. ZIP file, PDF set). This feature saves time for audit teams and ensures complete document presentation.

Secure Access Logs
Every access to archived data is logged with a timestamp. This system forms the basis for data security monitoring and audit traceability.