Electronic Batch Records –
Software Solution for GMP Manufacturing
Implement EBR in months, not years
The Benefits of ICE BatchManager®
Ensure compliance with minimal overhead
Built-in signatures and workflow guidance based on the ISA88 standard make it easy to create, edit, and approve processes.
Accelerate release time
Review by Exception speeds up release, reduces GMP bottlenecks, and improves Right-First-Time execution with full process visibility and control.
What sets ICE BatchManager® apart
Designed for real-life GMP production with intelligent features like workflow guidance, input validation, Review by Exception, and release workflows.
Fast implementation with low risk and maximum result, gaining the benefits of Right-First-Time and Review by Exception from day one, without long and disruptive redesign projects.
Continuous improvement without extra compliance overhead by using built-in electronic review and approval flows for updating recipes and improving processes.
What our clients say
“Before ICE BatchManager®, we filled 20 binders per month with handwritten documentation. Now everything is digital, structured, and secure, making our QA and audit processes much more efficient.”
Carsten Naumann
Responsible Production Supervisor at Axplora Raubling
Implement EBR with maximum results and minimum risk
Implementation
No-code configuration and fast implementation for minimum risk and maximum result.
Operation
Intuitive and efficient execution with focus on Right-First-Time, Review by Exception, and electronic batch release.
Continuous Improvement
Phased optimization with minimal compliance overhead.
How to Implement ICE BatchManager®
ICE BatchManager® transforms EBR implementation into a fast, low-risk process. Instead of heavy upfront optimization, you refine stepwise, reaping the benefits from day one. With ICE, full implementation can be done in months, not years.
Our customers experience
%
Reduction of review time
%
Right-First-Time
%
Annual ROI
Improving manufacturing performance
Operations
Continuous improvements without risk
- Transform EBR implementation into manageable, low-risk steps
- Real-time KPIs and trend reports (APRs, XReports) support smarter decisions and ongoing process optimization
- No-code recipe builder empowers process experts to configure and maintain workflows—no IT support needed
Quality assurance
Compliance made effortless
- Quality Assurance stays in full control over configuration, with no IT support needed.
- Built-in workflow guidance, input validation, and ISA 88 templates ensure consistent, compliant processes.
- Review-by-exception and faster data validation accelerate batch release.
- Version control, electronic signatures, and on-demand reporting keep you audit-ready at all times.
IT
EBR system with minimal overhead
- Quick implementation and validation with minimal project management
- Easy integration with any ERP system
- Process experts manage recipes and workflows—IT stays out of day-to-day operations
- Stable, secure infrastructure backed by responsive ICE support
Electronic Batch Records for high-performance GMP Manufacturing
ICE BatchManager® delivers compliant, traceable, and error-resistant batch execution for modern life science production – built to support reliable operations and consistent product quality.
ICE BatchManager – tailored to GMP-regulated industries
Pharmaceutical companies
Generic drug manufacturers
API manufacturers
CMC manufacturers & CDMO partner
Vaccine manufacturers
Medical device manufacturers
Nutraceutical and functional food producers
Regulated cosmetics manufacturers
FAQ
ICE BatchManager – Frequently Asked Questions
Do we need to optimize our manufacturing processes before implementing ICE BatchManager Electronic Batch Record (EBR) software?
No, it is not necessary. ICE BatchManager is designed to adapt to your existing GMP manufacturing workflows. Most clients benefit from starting with a direct digitalization of their current batch records and SOPs. This approach allows for quick gains in Review-by-Exception, improved Right-First-Time (RFT), and overall batch documentation accuracy—without needing upfront process optimization or automation.
Are coding or IT skills required to configure recipes in ICE BatchManager®?
No. ICE BatchManager® is a no-code Electronic Batch Record system. It uses the ISA-88 batch model standard and graphical process flow that lets recipe administrators create and modify master batch records without writing a single line of code. This enables rapid configuration, easy updates, and reduced IT dependency.
How long does it typically take to implement ICE BatchManager® as our EBR system?
A typical full implementation—including configuration, validation, and user training—takes between 6 to 9 months. If time is a priority, it can be done faster.
Can ICE BatchManager® integrate with our existing manufacturing equipment and control systems?
Yes. ICE BatchManager® supports integration with the process and relevant IT systems.
Can you use ICE BatchManager® for Annual Product Review (APR)?
Yes. ICE BatchManager® includes a reporting feature called X-Reports, which allows users to filter critical process parameters across multiple batches. This functionality helps manufacturers monitor process stability, detect deviations early, and ensure regulatory compliance.
Can you use ICE BatchManager® together with ICE Equipment Log?
Yes, these software solutions are designed to complement each other. Together, the ICE BatchManager® and the ICE Equipment Log provide complete documentation of both batch execution and equipment history.
Is ICE BatchManager® designed for CFR 21 Part 11 and GMP usage?
Yes. It’s built for the real-world challenges of GMP manufacturing and is fully compliant with CFR 21 Part 11. A validation package is also available.
ICE Solutions
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+45 4824 3560
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