Process XE

Sarjen's Manufacturing Process Automation solution, branded as Process XE, is a purpose-built Manufacturing Execution System (MES) designed exclusively for the rigorous requirements of pharmaceutical manufacturing. It functions as the crucial bridge between the enterprise resource planning (ERP) layer and the physical shop floor, aiming to eliminate paper processes and achieve true paperless manufacturing.

Core Regulatory Compliance

The system is engineered to ensure adherence to the highest regulatory and data integrity standards required in the life sciences industry. Key compliance features include:

21 CFR Part 11 Readiness: Process XE provides the required controls for electronic records and electronic signatures, making it compliant with the US FDA regulations.

ALCOA+ Compliance: It enforces data quality standards (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) for all manufacturing data capture.

GxP Data Integrity: The system uses real-time data capture and controlled workflows to ensure the traceability, accuracy, and security of all production data.

Key Modules and Features

Process XE integrates several essential functions to manage and execute manufacturing operations efficiently:

1. Electronic Batch Records (eBMR/eBPR)

The system digitizes the entire Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR). It guides operators through the process steps, enforces checks and balances, and automatically records data, eliminating manual transcription errors and ensuring that batches are manufactured 'right first time.' This digital record creation significantly speeds up the batch review and release process.

2. Weighing and Dispensing Management System (WDMS)

The system controls the precise dispensing of raw materials. It interfaces directly with weighing scales, ensures accurate weighing against defined limits, and uses barcode scanning or other verification methods to confirm the identity of materials and operators. This is a critical step in preventing costly dispensing errors.

3. Electronic Logbooks (eLogbooks)

Process XE replaces traditional paper logbooks for critical manufacturing assets (e.g., equipment, rooms, instruments). It automatically records equipment usage, cleaning status, maintenance history, and calibration records, making it easy to track the status and history of any asset in real-time, thereby improving compliance and utilization.

4. Process and Equipment Management

The system streamlines the management of equipment lifecycle and process monitoring, featuring: Equipment Qualification and Calibration Tracking: Ensuring all manufacturing equipment is qualified, maintained, and calibrated according to schedule.

CPP/CPV (Critical Process Parameters/Continuous Process Verification): Monitoring key process parameters in real-time to maintain quality consistency and facilitate ongoing process improvement.