Operator and Personnel Records Management

The Operator and Personnel Record Management Module tracks every step of the personnel in the production processes in a digital environment. It facilitates workforce management with shift information, task assignments and competency status. Thus, it is clearly recorded which operation each operator performs, when and with which parameters.

This module is especially critical in GxP/GMP processes. Personnel responsibility and transaction history can be transparently monitored, training deficiencies can be identified and efficiency can be increased. Process security is ensured thanks to steps requiring digital approval and double signatures.

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Operator and Personnel Records Management Module

The Operator and Personnel Records Management Module digitally records personnel tasks, competency levels and transaction history. This module optimizes workforce management, ensures process security and monitors personnel performance, thereby increasing process efficiency.

Authorization

Digital Recording

Task Tracking

Approval Management

Performance

Personnel Identification and Authorization

Each employee is defined in the system with roles, duties, expertise and authorization levels. Thus, the user can only see and perform operations within their own area of authority.

Solutions

User Information Definition
Determination of Jurisdictions
Authorization Change Monitoring
Transaction Authorization Control

User Information Definition
Information such as name-surname, department, position, authority level is defined. This determines the role and field of duty of each personnel in the system.

Determining the Areas of Authority
It is determined which modules and process steps they can access. In this way, each personnel is ensured to perform operations only in the areas they are authorized to.

Permission Change Tracking
Permission change history is logged and auditable. This allows changes to user permissions to be tracked and audited, thus improving security and process management.

Transaction Authorization Control
Only authorized users can perform approval or intervention operations. This feature prevents unauthorized intervention in transaction processes and provides security.

Transaction Based Digital Recording and Authentication

In each transaction, the identity of the personnel performing the transaction is verified by the system with username/password, digital signature or biometric verification. In this way, it is clear who is doing what.

Solutions

Identity Verification
Transaction Logging
Critical Transaction Security
Unauthorized Warning

Authentication
The operator logs into the system with authentication before the transaction starts. This ensures that each user is authenticated before the transaction, thus preventing unauthorized access.

Transaction Logging:
Username, transaction time and transaction type are recorded for each transaction. This feature provides traceability by recording who performed the transaction, when and with what transaction.

Critical Transaction Security
Critical transactions require cryptographic confirmation or double verification. This increases the security of sensitive and important transactions and prevents false interventions.

Unauthorized Warning
Unauthorized transaction attempts are recorded and the system warns. In this way, when unauthorized persons try to perform transactions, the system warns and takes precautions against security breaches.

Shift and Duty Tracking

The system tracks which personnel are on which shift and in which task. Shift changes, intra-shift task assignments and transfers are recorded.

Features

Shift Planning
Input-Output Logs
Handover Records
Shift Control

Shift Planning
Daily shift planning is defined in the system. This determines in advance which shift the personnel will be assigned to and makes it easier to manage the current shift order.

Entry-Exit Logs
Staff entry-exit times are digitally logged (card, pin, RFID etc.). This is integrated into the shift tracking system and ensures the accuracy of staff working hours.

Handover Records
Brief notes or handover records are entered at shift changes. This process ensures that the transition from one shift to another is smooth and orderly.

Shift Control
Off-shift personnel can be prevented from performing tasks or can be subject to approval. This feature ensures security and order by preventing unauthorized persons from performing tasks.

Transaction Approval and Double Signature Management

Some critical production steps must be approved not only by a single operator but also by a second person. This component manages the double signature, review, and transaction locking processes.

Features

Dual Role Definition
Digital Approval Flow
Approval Ranking
Rejection or Waiting Status

Dual Role Definition
A second user is defined for critical steps (e.g. supervisor). This ensures that important operations are completed correctly and safely.

Digital Approval Flow
The transaction will not proceed until digital approval is received from both users. This feature provides an additional layer of security to verify the accuracy of each critical step.

Approval Ordering
Approval ordering and timestamps are kept in the system. This makes it possible to transparently track the order of approval processes and when they occurred.

Rejection or Pending Status
It is mandatory to enter a reason for rejected or pending transactions. This increases traceability of processes by recording why transactions are rejected or pending.

Monitoring Staff Performance and Transaction History

The past transactions, approvals, interventions and error/deviation attempts of each employee can be monitored and reported by the system.

Features

Retrospective View
Performance Analysis
Audit Reports
Dashboard

Historical Tracking
User-based transaction history can be queried on a time-based basis. This allows you to quickly review each employee's past transaction records and evaluate their past performance.

Performance Analysis
Repetitive errors, response times and workload can be analyzed. This analysis objectively evaluates staff performance and provides improvement opportunities to increase efficiency.

Audit Reports
Personnel transaction records in audits can be exported as PDF/Excel. This ensures that personnel activities in audit processes are transparent and documented.

Dashboard:
Employee performance can be monitored via a dashboard specific to managers. This feature makes it easier for managers to visually track performance indicators and make quick decisions.