ICE BatchManager®

ICE BatchManager®

Get faster batch release with ICE BatchManager®. Replace paper-based solutions with electronic guided workflows and electronic batch recording. Reduce batch preparation work, avoid common errors in paper-based batch documentation, and improve Right-First-Time. Get Review-by-Exception and electronic batch recording that can be implemented in just a few months.

ICE BatchManager® is designed for CFR 21 Part 11 compliance and for agile and efficient usage in a regulated environment.

Improve product quality and avoid documentation errors with electronic batch records

Electronic batch records (EBR) software – also known as electronic batch manufacturing records (EBMR) software – is a software solution that can help automate batch recording processes and remove the burden of documentation, review, and release from quality and manufacturing teams.

In pharmaceuticals, biotech, and other life science industries, batch records are critical for companies to meet regulatory requirements. However, due to concerns surrounding the length, complexity, and success rate of implementation processes, many pharmaceutical manufacturing companies still use paper-based records – a documentation form that is often both inefficient and resource heavy.

Paper-based, handwritten documentation is subject to human error, which exposes manufacturers to serious GMP compliance risks. It lowers Right-First-Time on batch documentation, which causes long batch release time, and it often costs many production and quality assurance resources to correct errors, write reports, and take extra samples.

An electronic batch records system can minimise these risks. By replacing paper-based batch documentation with EBMR software, it is possible to improve Right-First-Time and product quality, as well as avoid documentation errors and compliance issues.

Get faster batch release with ICE BatchManager®

ICE BatchManager® is an electronic batch manufacturing records (EBMR) system designed to meet the increasing demands for flexibility and productivity of validated manufacturing processes.

With ICE BatchManager®, you can achieve:

• CFR 21 Part 11 compliance
• Implementation in just a few months
• Improved Right-First-Time and reduced release time
• Easy operation and low maintenance

Ensure batch records compliance with ICE BatchManager®

ICE BatchManager® is built for the complex compliance needs of life sciences industries such as pharmaceuticals and biotech. The EBMR system ensures CFR 21 Part 11 compliance and provides electronic signatures, ensuring GMP and minimising risks of non-compliance.

BatchManager® generates electronic batch records and replaces paper-based procedures with electronically guided workflows. The system comes with a pre-qualification package, enabling users to notably reduce the time spent on qualification, thus speeding up the validation process by up to one year.

The EBMR software also provides input validation, minimising the risk of error on entry.

Get easy configuration and implementation in just a few months

ICE BatchManager® allows for dynamic, step-wise implementation. The solution is intuitive, easy to use, and offers guided workflows. ICE BatchManager® is easily configurable and designed for use in the life science industry with minimal overhead.

This means that the solution can be implemented in only a few months, allowing you to optimise procedures and achieve the benefits of improved RFT and Review-by-Exception with minimal first steps that do not necessarily require change to existing facilities.

With BatchManager®, creating and configuring effective procedures and recipes is easy.

The system provides:

• Easy and intuitive operation and high user acceptance
• Effective and easy-to-follow workflow guidance throughout the batch process
• Easy configuration and implementation of changes to procedures and recipes without the need for supplier involvementProcess responsibles can review, configure, and approve changes to procedures and recipes when needed without the need for revalidating the system. This makes it easy to implement improvements and changes to processes and removes the overhead of revalidation and supplier involvement.These features allow you to achieve the benefits of BatchManager® with minimal need for operator training. Furthermore, no IT knowledge is required to build or administer recipes. This can be done by the process experts.

Improve Right-First-Time (RFT) and reduce release time

ICE BatchManager® enables you to avoid common errors in paper-based batch documentation, allowing you to greatly improve Right-First-Time (RFT) – a benefit further supported by Review-by-Exception.

In paper-based batch documentation, the review is a time consuming process. BatchManager® offers Review-by-Exception, which highlights all exceptions in batch documentation.

Review-by-Exception allows your quality assurance and manufacturing teams to review batch documentation by exceptions, viewing only input that does not meet expected results. Review-by-Exception thus makes it possible to avoid spending valuable time and resources manually reviewing hundreds of pages’ worth of batch documentation, simultaneously guaranteeing that no exceptions are missed or not found.

With Review-by-Exception, ICE BatchManager® immediately notifies you of exceptions in batch documentation, allowing your quality assurance and site management teams to take corrective measures or approve exceptions directly.

This way, Review-by-Exception helps you save valuable time and resources in the release stage.

Easy operation – low maintenance

ICE BatchManager® allows you to achieve the benefits of improved RFT and Review-by-Exception.

The electronic batch record system is hardware independent. The solution can be accessed on any device through your preferred browser; you do not need to install any software on clients to use the system. This allows thousands of users to access and use the system with no overhead to administer clients or client software.

ICE BatchManager® is easy to maintain and a fully scalable solution.

The solution offers:

• A small IT footprint
• Easy integration with process equipment and other IT systems
• Seamless integration with ICE EquipmentLog®

These features drastically reduce the time and resources spent on IT operations, allowing site management to focus on batch processing instead.

ICE BatchManager® enables the huge benefits of improved Right-First-Time and Review-by-Exception much faster and easier than you might imagine. This and the benefits above make ICE BatchManager® likely to be the most effective and agile EBMR solution available.