Production Record Management Module - E-logbooks eLogs

Production Record Management

It prevents manual errors by recording every stage of the production process digitally. All processes in the production line are recorded with a time stamp, thus ensuring data security and increasing traceability. Thanks to this system, quality standards are met more easily.

Efficiency and transparency increase. In case of any production disruption, the system offers real-time alerts and intervention. Fast and accurate recording of production data optimizes the production processes of businesses by providing reliable evidence in audits.

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Production Record Management Module

The Production Process Record Management Module enables all movements in the production line to be recorded digitally.

Process Data Management

Data Recording

Approval Mechanism

Incident Records

Party Based Records

Process Identification and Monitoring

Each step in the production process is defined on the system (e.g. granulation, drying, coating). The order of these steps, their inputs and expected parameter ranges are determined.

Features

Creating Process Flow
Determining Parameter Ranges
Critical Control Points
Time Stamped Record

Creating a Process Flow
The process flow chart is defined. In this step, each production process step is followed in the correct order and its requirements are clearly determined. The flow chart is a guide that shows the relationship and order of process steps.

Determination of Parameter Ranges
Target temperature, time, rpm, etc. parameter ranges are determined for each process. This feature ensures that the specific parameters required in each step are kept at the correct values. Target values maintain production efficiency and quality standards.

Critical Control Points
Mandatory operator approval or double-checking is implemented for critical steps. This ensures that critical steps are monitored and approved. Operators provide approvals or apply double-checking mechanisms to ensure the accuracy of processes.

Timestamped Log
A timestamped log is created for each step’s completion. This feature allows data to be recorded for when each process started and was completed. Timestamps ensure that the production process proceeds on time and in an orderly manner.

Instant Process Data Recording (Online/Offline)

Physical data such as temperature, humidity, rpm coming from the equipment are recorded automatically. Manual entry screens are presented for cases where no data is received from the automation system.

Features

Data Integration
Periodic Record
Manual Entry
User and Time Information

Data Integration
Data integration is done from SCADA/DCS/PLC systems. This ensures that data from the equipment is transferred to the system in real time. The integrated data constitutes the basic information source used in monitoring and control processes.

Periodic Recording
Data is captured at regular intervals and written to log records. This feature ensures that data is recorded regularly and increases traceability. Data intervals are determined according to the requirements of the system.

Manual Entry
User authorization is checked for data that requires manual entry. This feature ensures that data is entered correctly manually, ensuring that data recording continues even when the automatic data flow is interrupted.

User and Time Information
All data is recorded with a time stamp and user information. This allows tracking of the time period and by which user the data was entered, increasing the auditability of the transaction history.

Approval and Review Mechanism

Each data collected and process step in the process cannot be passed to the next stage without approval by the operator. Critical processes may require supervisor or quality unit approval.

Features

Approval Roles Definition
Digital Signature Process
Block Unapproved Transactions
Lockdown and Report Preparation

Approval Roles Definition
Primary approval (operator) and secondary approval (supervisor) are defined for each process. This feature ensures that each step is subject to a two-stage approval process, thus increasing the accuracy and quality control of the processes.

Digital Signature Process
Approvals are made by digital signature or user verification. This ensures that each approval is secure and traceable. The digital signature process verifies the approvals of operators and supervisors, thus securing data entries and transaction approvals.

Unapproved Transaction Block
Unapproved data entry is blocked or the system gives a warning. This feature ensures that each transaction step does not proceed to the next stage without approval, thus preventing incomplete or erroneous data from progressing through the system.

Locking and Report Preparation
Locked records are created for post-review reporting. This ensures that data that has completed the approval process cannot be changed and that accurate and reliable data is used for reporting.

Event and Deviation Records

Unexpected events, process deviations, stoppages or manual interventions occurring during production are recorded and the CAPA process is initiated when necessary.

Features

Event Category Selection
Time and Location Information
Marking Affected Processes
Disclosure and Approval

Incident Category Selection
The digital form is filled in by selecting the incident type (stop, deviation, emergency response, etc.). This allows the necessary information collection and analysis processes to be initiated according to the type of incident. Correct categorization of the incident helps to quickly resolve the problem.

Time and Location Information
The relevant step and time stamp are automatically captured by the system. This clarifies when and at which production stage the incident occurred. Time and location information increases the traceability of the incident and provides an important reference in the solution process.

Marking Affected Processes
The process steps affected by the incident are marked. Identifying the affected steps helps identify which stages of the process are experiencing problems. This process ensures that the problem is addressed correctly.

Explanation and Approval
Manager approval or explanation is required for the process to continue. Manager approval or additional explanations are required for the solution and improvement process related to the incident. This is important for the initiation of the CAPA (Corrective and Preventive Action) process and for the correct direction of the actions to be taken later.

Batch Based Record Creation and Archiving

All production process records are grouped according to the relevant batch number. These records are easily accessed when retrospective analysis, auditing or reminders are required.

Features

Batch Definition
Automatic Connection
Record Lock
Digital Archive

Batch Definition
A batch number is created at the beginning of production and all records are collected under this number. This ensures that all production data is grouped as belonging to a specific batch. The batch number increases the traceability of the production process.

Automatic Linking
Each process step is automatically linked to the relevant batch. This feature ensures that processes are correctly linked in the system so that each step is linked to the correct batch number.

Record Locking
When a batch is completed, the system locks the record and puts it in read-only mode. This prevents any changes to the records after the batch, thus ensuring that the data is stored securely and without errors.

Digital Archive
Digital archiving is done; records are kept in PDF or database format. This allows easy access to records and enables analysis or auditing of historical data when necessary.