Equipment Log Management - E-logbook eLogs

Equipment Records Management

The Equipment and Device Record Management Module securely records the performance, maintenance history and calibration status of all devices used in production processes in a digital environment. The usage history, cleaning and maintenance processes of each device can be tracked in detail. This module increases efficiency and prevents potential failures by constantly monitoring your equipment.

The module organizes the usage status and maintenance schedule of devices in a central system, so that each device is automatically notified when it needs to be maintained. Calibration, cleaning and fault records are stored in the system in a time-stamped and verifiable manner, ensuring device traceability. In this way, businesses ensure the continuity of their production processes and fully comply with quality standards such as GMP and GLP.

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Equipment Records Management Module

The Equipment and Device Record Management Module tracks the usage history of devices, maintenance, calibration and cleaning processes in a digital environment. It provides full traceability of all operational statuses, maintenance and fault records and processes.

Device Operations

Operational Processes

Cleaning Records

Calibration and Performance

Incident Report

Device Identification and Classification

All devices and equipment are recorded on the system with unique definitions. These definitions include information such as the type of device, place of use, production line relationship and calibration type.

Features

Device Information Entry
Type Based Classification
Line Matching
Calibration Status Definition

Device Information Entry
Device code, name, brand-model and location information is entered. This ensures that each device is correctly identified and traceable. All information about the device is recorded in the system and can be easily accessed.

Type-Based Classification
Classification is done based on the type of device (reactor, mixer, weigher, etc.). This ensures that devices are correctly classified and managed according to their function.

Line Matching:
Usage permissions and production line relationships are defined. By determining which production line and when the devices will be used, efficiency is ensured in operational processes.

Calibration Status Definition
The validation and calibration status of the device is entered into the system. This is important to keep track of when the devices need to be calibrated and which standards they are operating in accordance with.

Usage and Operational Status Tracking

It records which process, when, by whom and with which parameters a device is used during production. In this way, all operational traces are kept digitally.

Features

Device Selection
Usage Time Record
User Information
Limit Value Warning

Equipment Selection
Equipment selection is required at the beginning of the process (by drop-down or barcode). This ensures that the correct device is used in each process and helps ensure that the operational process is followed correctly.

Usage Duration Recording
Usage start and end times are logged. This record provides clear information about the usage duration and efficiency of the device, allowing the performance of the device to be evaluated in each use.

User Information
User identification (ID) and transaction details are recorded. This makes it possible to track which operator used which device and when it was used in which transaction, thus increasing traceability of the production process.

Limit Value Warning
If the device is used with out-of-limit parameters, the system will give a warning. This feature informs operators in case the devices are used outside the specified parameter ranges and prevents operational errors.

Cleaning and Preparation Records

Cleaning operations performed before and after each use of the device are entered into the system in a digital logbook format. Type of cleaning, chemicals used, person performing the cleaning and verifier information are recorded.

Features

Cleaning Type Selection
Time Recording
Chemical List
Operator Approval

Cleaning Type Selection
The cleaning type is selected (CIP, SIP, manual). This option allows different procedures to be applied depending on the type of cleaning performed and helps to classify the cleaning process correctly.

Time Recording
The date and time of cleaning are recorded by the system. This record allows you to track when the cleaning process was performed and the maintenance schedules.

Chemical List
Lists the cleaning agents used. Keeping track of which chemicals are used during the cleaning process helps ensure compliance with hygiene standards and safety requirements.

Operator Approval
Approval from the operator and the validating personnel is recorded with a digital signature. This provides documentation that the cleaning process has been performed correctly and approved by the validating personnel.

Maintenance and Calibration Process Records

Planned or fault-related maintenance, periodic calibration and validation processes of the devices are planned through the system and each step is written into the logbook.

Features

Calendar Planning
Process Checklist
Status Update
Authorized Approval

Schedule Planning
A schedule of periodic maintenance and calibration is created. This ensures that maintenance and calibration processes are carried out on time, thus ensuring that the devices are in continuous operation.

Process Checklist
All steps are digitally marked (checklist) as the process is carried out. This ensures that every stage of the maintenance and calibration processes is completed and recorded.

Status Update
After the process is completed, the "ready for use" or "not available for use" information is updated. This allows accurate monitoring of the device's status and clarifies the usability of the device after the process.

Authorized Approval
The record is locked through approval and review processes. This ensures the accuracy and completion of the transaction and ensures that processes are followed correctly.

Device Event and Status Logs

Device-related events such as faults, alarms, warnings, deactivation or temporary unavailability are automatically or manually recorded in digital event logs.

Features

Incident Detection
Intervention Record
Impact Analysis
CAPA Connection

Event Detection
When an alarm or fault occurs in the device, the system records the event. This allows the system to keep a record of the event in case of any fault or alarm in the device.

Intervention Log
The explanations and interventions made by the user are added. This keeps a record of all interventions and solution steps taken regarding the problem on the device.

Impact Analysis
The impact of the event on the production process is indicated (whether the process was stopped or continued). This evaluates the effects of the event on the production line and indicates whether the production process was interrupted or not.

CAPA Link
If corrective action has been initiated, this is also linked to the incident record. This allows tracking of corrective actions taken regarding the incident and systematic follow-up of the improvement process.