The Future of Traceability and Compliance

Need for this
The Future of Traceability and Compliance

Pharmaceutical industries require precise record-keeping to ensure product quality, regulatory compliance, and operational efficiency. Traditional paper logbooks are prone to errors, inefficiencies, and compliance risks, making audits and data retrieval clumsy.

The need for a solution arises to: 

Eliminate manual errors in documentation.
Ensure regulatory compliance with secure, traceable records.
Improve efficiency through automation and real-time access.
Streamline audits with structured, searchable logs.
Enhance data integrity with secure digital records.
Benefits of Implementing eLogbooks

Adopting electronic logbooks offers numerous advantages: 

Enhanced Data Integrity

Automated data capture minimizes human errors, ensuring accurate and consistent records.

Regulatory Compliance

eLogbooks facilitate adherence to regulatory requirements by providing secure, traceable, and tamper-proof records.

Improved Efficiency

Digital records enable quick data retrieval, streamline workflows, and reduce administrative burdens.

Real-Time Monitoring

Instant data access supports proactive decision-making and swift responses to operational issues.
Process Diagram
1

Logbook Creation

Users create a new eLogbook, defining parameters such as equipment, batch details, and compliance requirements.
2

Logbook Approval 

Review, approval and publishing of the logbook, ensuring compliance with regulatory requirements.
3

Logbook Issuance

The approved logbook is assigned to relevant personnel for execution.
4

Logbook Execution 

Operators record real-time data, including equipment usage, maintenance, and cleaning activities.
5

Data Validation

The system automatically checks entries for completeness and accuracy, prompting corrections if necessary.
6

Data Storage

Validated data is securely stored in a centralized database, ensuring easy access and protection against data loss.
7

Data Access

Authorized personnel can retrieve and review data in real-time, facilitating monitoring and decision-making.
8

Reporting and Analytics

The system generates reports and analytics to support audits, compliance checks, and continuous improvement efforts.
eLogbook with Process XE®

Sarjen Systems’ Process XE® eLogbook integrates seamlessly with enterprise systems such as Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), and Electronic Batch Records (EBR). It automates logbook creation, approval, and execution, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements like 21 CFR Part 11. The system provides real-time monitoring, automated alerts, and controlled access, enhancing data integrity and operational efficiency. Every entry is securely documented with an audit trail, ensuring traceability and compliance readiness for audits and inspections. 

Results of Implementation
Pharmaceutical companies implementing Process XE’s® eLogbook have reported significant improvements: 

95% Reduction in manual errors

in logbook entries and documentation.

90% Improvement in compliance

with automated audit trails and real-time monitoring.

85% Faster logbook review and approvals

through streamlined digital workflows.

60% Increase in operational efficiency

with automated scheduling and alerts.