Electronic Batch Records (EBR) For Pharma And Biopharma

Electronic Batch Records (EBR) For Pharma And Biopharma

A cloud-based digital solution that will help you streamline your production, reduce quality defects and ensure compliance & auditability. Built exclusively for Pharma & Biopharma manufacturers, the software is pre-validated & built on modern technology, enabling faster and more robust implementations.

Electronic Batch Records (EBR) For Pharma And Biopharma

End2End Digitization

REVIEW BY EXCEPTION
REVIEW BY EXCEPTION

Optimize reviews of quality events with review-by-exception and efficient workflows. All the information for each batch is readily available for evaluation by the respective experts in the factory, thus minimizing review time.

PRE-VALIDATED SOLUTION
PRE-VALIDATED SOLUTION

Out-of-the-box validation package that saves you at least two months of effort during the implementation period.

POWERFUL INTEGRATIONS
POWERFUL INTEGRATIONS

Designed to integrate seamlessly with your existing systems, so you can get up and running quickly without disrupting your operations or needing to invest in new infrastructure.

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Electronic Batch Records (EBR) For Pharma And Biopharma

Made for Pharma / Biopharma

Built exclusively for Pharma and Biopharma, Electronic Batch Records can easily adapt to your business needs, significantly reducing implementation, validation, and training efforts, allowing rapid go-live and easy maintenance. Electronic Batch Records is a pre-validated solution that is:
  • Designed to meet the regulatory compliance requirements, including FDA, GMP, and FDA Title 21 CFR Part 11, to ensure data and processes are secure, validated, and auditable
  • Available with an out-of-the-box validation package (including IQ/OQ), which saves at least two months of effort during the implementation period
  • Flexible enough to adapt to changing regulatory requirements, new products, and process changes without requiring significant customization
  • Scalable and able to handle the increasing demands of a growing pharmaceutical manufacturing operation, including multiple sites and global operations
  • Integrates with IoT devices such as smart sensors and wearables to provide real-time feedback on critical parameters and improve data quality

The above benefits, combined with the support of our experienced consulting team, will help guide you during this digital journey with guaranteed success.

Accelerate Time to Market & Simultaneously Improve Quality

Automated Data Entry and Real-Time Tracking
Eliminate manual data entry and track your production in real-time, giving you complete visibility into your operations and allowing you to make data-driven decisions that improve efficiency and time to market.

Time Reduction in Review Cycles
Improve quality and compliance through the right-first-time execution of procedures and automated checks for non-conformities by eliminating non-added value QA tasks.

Configurable Workflows and User Permissions
Easily configure workflows and user permissions to match your specific production processes, ensuring compliance with regulatory requirements and improving efficiency by reducing errors and delays.

Advanced Reporting and Dashboards
Make it easy to generate reports and analyze production data, so you can identify trends, spot areas for improvement, and make informed decisions that drive operational efficiency and quality.

Flexible & Scalable Recipe Creation
Flexible workflows that can adapt to changing regulations, products, and processes without requiring significant customization & reducing the investment in recipe maintenance.

Automated Alerts
The Electronic Batch Records system offers automated alerts for production critical events, like exceptions and deviations, that allow you to minimize resolution times.

Equipment/Material/Room Scanning and Label Printing
Assets on the shop floor can be efficiently tracked using the system. Barcode scanner integration allows easy identification of equipment, rooms, and materials during the production process.

Device Agnostic
Vimachem’s Electronic Batch Records is a cloud-based service offering you the flexibility to access your data from anywhere and on any device.

Embed Quality into your Execution Process

GxP FEATURES

USER LEVEL PERMISSIONS & SECURITY
USER LEVEL PERMISSIONS & SECURITY

Manage roles and permissions to keep data safe. User administration in a Windows Active Directory simplifies the definition of password criteria, reset and change periods, and reduces IT support demands.

DATA INTEGRITY
DATA INTEGRITY

The system is verified for data integrity, with advanced controls that allow verification of inputs during the operation and controlled access with role-based access management.

ELECTRONIC RECORDS & SIGNATURES
ELECTRONIC RECORDS & SIGNATURES

Fully compliant with FDA Title 21 CFR Part 11 and EU GMP Annex 11 (Electronic Records and Signatures).

DIGITAL RECORDS
DIGITAL RECORDS

The system holds digital records of every operation on the shop floor, including device records and equipment logs.

ELECTRONIC SIGNATURES
ELECTRONIC SIGNATURES

Efficient review and approval through configurable workflows ensure quality remains consistent during the production process.

DATA EXPORTS
DATA EXPORTS

All data can be exported manually and automatically in Microsoft® Excel® (XLSX) and Extended Markup Language (XML) formats.

READY TO AUGMENT YOUR SHOP FLOOR OPERATIONS?

READY TO AUGMENT YOUR SHOP FLOOR OPERATIONS?

Get started with real-time manufacturing analytics today.

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