User's guide /

Batch record management

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General Information

Welcome to ProFlow Batch Record Management

ProFlow Batch Record Management is a fully digitalized and GMP-compliant solution designed to streamline batch record handling in pharmaceutical manufacturing. By automating batch record creation, approval workflows, and digital signing, ProFlow ensures full compliance, document security, and operational efficiency.

Key Features

  • Automated batch record generation directly from integrated equipment
  • Approval workflows that ensure compliance and reduce manual intervention
  • Electronic signature integration supporting multiple providers
  • Comprehensive audit trail ensuring traceability and regulatory alignment
  • Secure document locking to maintain data integrity and prevent modifications
  • Role-based access control for secure document handling
  • Automated notifications for streamlined communication and approval tracking

Process Overview

The system follows a structured and compliant batch record lifecycle, ensuring complete control over documentation, approval, and compliance processes. With integrated equipment data capture, automated approvals, and secure digital signing, ProFlow provides an end-to-end solution for managing batch records efficiently.

Batch Record Lifecycle
Batch Record Lifecycle

Track batch documentation from generation to final approval.

Equipment Integration
Equipment Integration

Seamless data capture from production equipment.

Digital Signing
Digital Signing

Secure electronic signatures for batch approvals.

Audit Trail & Compliance
Audit Trail & Compliance

Full traceability ensuring regulatory compliance.

User Roles & Access
User Roles & Access

Manage permissions and ensure secure role-based access.

Automated Notifications
Automated Notifications

Stay informed with automated alerts and reminders.