Electronic Batch Records (EBR) For Pharma And 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 ...