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Digitizing Review and Release: Smarter Workflows, Faster Reviews, Stronger Compliance with Vimachem eBR
Digitizing Review and Release: Smarter Workflows, Faster Reviews, Stronger Compliance with Vimachem eBR
Emma Hanley
Senior Product Marketing Manager
In pharma manufacturing, batch review and release can be a bottleneck. Paper-based processes slow production, introduce human error, and delay delivery, while regulators demand precision and proof at every step.
Vimachem’s Electronic Batch Records (eBR) module transforms this process, making review and release faster, more transparent, and inherently compliant.
Live Execution, Instant Visibility
From the Main View, teams can quickly navigate to the eBR workspace and see the full batch lifecycle in one place. The Ops View provides operators with step-by-step instructions, in-process checks, and real-time data capture, all tailored to the Master Batch Record.
Every action is validated as it happens, meaning reviewers aren’t waiting for paperwork at the end of production. By the time a batch reaches review, the data is already accurate, complete, and ready for approval.
EBR Overview
Smarter Review, Fewer Delays
Instead of review being an afterthought, Vimachem eBR enables concurrent review.
QA teams can:
- Monitor batch execution live.
- Flag and resolve deviations instantly.
- Approve steps without interrupting production.
The Batch Review View consolidates parameters, exceptions, attachments, and signatures into one navigable screen. Review cycles shrink from days to hours, and audit readiness becomes a continuous state rather than a last-minute scramble.
Built-In Compliance from Day One
Compliance isn’t an add-on, it’s embedded in the workflow.
The eBR module enforces GMP, FDA 21 CFR Part 11, and EU Annex 11 requirements at the point of data entry with:
- Mandatory validations for critical fields.
- Automated timestamps and e-signatures.
- Version-controlled instructions.
- Complete audit trails for every change.
Because compliance is automatic, review and release happen faster and with less risk.
Scale with Smart Workflow Flexibility
Whether managing a single site or a global network, Vimachem eBR adapts to your environment.
Dynamic workflows automatically adjust instructions, parameter limits, and approval steps based on:
- Batch size.
- Product potency.
- Site-specific requirements.
This flexibility ensures consistent compliance while enabling rapid deployment across facilities.
eBR Designer
Part of a Modular MES Platform
Vimachem eBR is part of the AI-driven Modular Pharma MES Platform. Its modular architecture means manufacturers can start with eBR and seamlessly expand into additional modules for greater control, efficiency, and compliance across operations.
Some of the most powerful combinations with eBR include:
- eBR & Weigh & Dispense – Production Operations: Ensures every material is weighed, verified, and automatically linked to the batch record, eliminating manual transcription and guaranteeing traceability from the very first step.
- eBR & Changeover Assistant – Packaging Operations: Speeds and standardizes line changeovers while maintaining full compliance, ensuring packaging runs start on time with minimal risk of error.
- eBR & Weigh & Dispense & Changeover Assistant & Logbooks – Integrated Production & Packaging: Enables the digitization of both batch and non-batch operations across production and packaging, with unified tracking and control from material preparation to final packaging.
By connecting modules, manufacturers can create a fully integrated workflow, from material preparation to packaging, ensuring every action is tracked, validated, and optimized for efficiency. These are just a few examples of how eBR can be combined with other Vimachem modules to deliver end-to-end operational visibility. For the full range of capabilities, explore the MES Platform page.
A Glimpse at Real-World Impact
A mid-size pharma site running 12 packaging lines reduced their average batch review cycle from three days to less than six hours by implementing Vimachem eBR. Real-time review meant deviations were addressed during execution, avoiding delays and ensuring every record was audit-ready at completion.
Your Path to Digital Review and Release
With Vimachem eBR, your review and release process is no longer a compliance hurdle – it’s a competitive advantage. to learn more, visit the eBR product page or take a product tour today.
Curious how it fits your operations?
Vimachem’s Pharma MES Platform offers a modular, cutting-edge solution that integrates a machine learning-driven GxP platform with specialized consulting and CSV services, supporting Pharma firms to transform their manufacturing operation in their digital journey to innovation.
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