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Electronic Batch Records (EBRs) System

Solutions

Cerexio EBR System: Electronic Batch Record System

Revolutionise your manufacturing processes in today's high-speed industrial landscape using the Cerexio EBR System– the ultimate global cloud-based Electronic Batch Record System. This solution is designed specifically for regulatory compliance in the Food, Beverage, and Pharmaceutical Industries. Safeguard stringent good manufacturing practices while streamlining and managing manufacturing EBRs, propelling you towards an incredibly successful future with less effort, time and investment!

Automate batch record processing smartly but effortlessly with Cerexio EBR System- the only industry 4.0-compatible Electronic Batch Record System

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Exceptional Reviewing

Enhance the efficiency of quality event assessments by utilising streamlined workflows that prioritise review-by-exception. This approach ensures that all batch-related information is easily accessible to factory experts, significantly reducing the time needed for reviews.

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Smart Multi-Integration Capacities

Created for effortless integration into your current systems, allowing for a swift setup that won't disrupt your operations or require additional investments in new infrastructure. This IoT-friendly solution delivers real-time feedback on vital parameters and enhanced data quality

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Automated Tracking and Tracing

Cerexio EBR System monitors and records all routing details and inputted data, enabling managers and stakeholders to track the entire process, pinpoint areas of congestion, and comprehend the chronological sequence of events throughout the processing stages.

Why Choose Cerexio EBR System?

Why do you need the Cerexio EBR System?

Cerexio EBR System is tailored to monitor all aspects of batch manufacturing. With Life Sciences companies embracing digital evolution, manufacturers increasingly employ manufacturing EBRs to oversee batch production data. These records encompass electronically or manually inputted data, aiming to demonstrate an organisation's meticulous documentation of crucial production stages. This is where Cerexio EBR System comes in; we help you digitise batch records for smarter resource and inventory management.

Automated data collection from various sources

Enhanced accuracy through data extraction automation

Comprehensive audit trail for process traceability

Automated alerts for deviations from standards

Controlled sequence for operations compliance

Improved data integrity and reliability

Reduced costs related to deviations and recalls

Enhanced user experience with intuitive workflows

Digitise Life-science and GxP Production in The Smartest Manner Possible with Cerexio EBR System

Moving from paper-based to electronic systems presents challenges such as employee resistance, system validation, and insufficiently defined requirements, increasing the risk of system failure. However, the Cerexio Electronic Batch Record System brings substantial and undeniable advantages to modern manufacturing. This EBR software drives efficiency, profitability, and a competitive advantage when effectively implemented and integrated with ERP and MES systems.
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Centralised Record Access Point

This EBR System offers a singular hub for comprehensive and convenient access to batch records. This feature streamlines data accessibility across various stakeholders and departments, ensuring efficient and synchronised access to critical information, enhancing collaboration, and expediting decision-making processes.

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MES-friendly Integration

Cerexio EBR System significantly reduces operational expenses by enhancing manufacturing compliance with regulatory standards through MES implementation. This involves replacing paper batch records with electronic ones (EBR), ensuring data integrity, and achieving legal requirements more effectively.

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Picklist Optimisation

It propels top-tier processes with its robust inventory management advantages, encompassing all-team access for accurate and swift material routing among Quality Assurance, Warehouse, and Production teams. It ensures uniformity and traceability across inventory stages while minimising errors and fostering confidence.

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Intuitive and User-friendly Dashboards

This solution enables a responsive and interactive dashboard for record keepers and decision-makers to complete tasks quicker, timely and effortlessly. It is easy for all users to get used to its tools, and they can organise the dashboard the way they prefer and get a more personalised experience, thus promoting a self-service analytics environment for all manufacturing decision-makers of your organisation.

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Mission-driven Configuration

This solution allows the user to configure electronic batch records based on the production value and manufacturing demands. The easy-search option allows the records to be linked with user-defined documents, making inspection, auditing and device master record keeping too easy.

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Reliable Compliance Integrators

Cerexio EBR System adheres to cGMP standards, specifically 21 CFR Parts 210-211, by generating time-stamped audit trails for document changes. Additionally, its integrated 21 CFR Part 11 compliant electronic signatures and automated workflows eliminate manual record circulation and pursuit of wet signatures.

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IoT-Integration

Cerexio EBR System stands out as the top-tier solution, encompassing tasks from integrating devices through IoT, conducting quality reviews, electronically approving batches (utilising review by exception), and managing batch record reporting and retention.

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Multi-level and Master Batch Control

Cerexio EBR System offers multi-level and master batch control, providing comprehensive oversight and management across various production stages and batches, ensuring efficient and synchronised control throughout the manufacturing process in GxP Production and Life Science-related Manufacturing.

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Smart Equipment Log

Centralised equipment summaries with colour-coded check-mark indicators, simplified management for various activities like calibration and maintenance, barcoded labels, scheduled alerts, and integrated document management. This ensures controlled availability, custom integration, and thorough traceability.

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Cerexio EBR Software

How does the Cerexio EBR System improve digital record management?

Cerexio EBR System revolutionises digital record management by automating data collection from diverse sources, minimising manual input errors and guaranteeing record accuracy. Real-time access to electronic batch records empowers stakeholders with swift data retrieval, expediting decision-making processes for its centralised platform and consolidating data, ensuring accessibility to all pertinent information from one location.

Join Cerexio to ensure in-factory compliance by maintaining a detailed audit trail that timestamps all changes, meeting regulatory standards for transparency and traceability. Its integration capabilities enable seamless synchronisation with other systems and devices, optimising overall efficiency and precision in digital record management processes. Here’s how Cerexio EBR System improve digital record management:

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Utilising the Cerexio EBR System, submit clear and unaltered reports to the regulatory agencies to guarantee the legitimacy, technological prowess, and trustworthiness of your production processes.

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All changes made to the records can be easily traced and tracked thanks to the system's careful audit trail maintenance. This feature offers an extensive history of modifications, guaranteeing dependability and transparency in the event of audits or inquiries.

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Robust version control mechanisms are built into the Cerexio EBR System to prevent unauthorised changes. By controlling access permissions and preventing unauthorised changes, it strengthens the authenticity and dependability of data while ensuring the security and integrity of documents.

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The platform facilitates fast access to historical records and insights by enabling efficient data retrieval and analysis. By offering thorough insights into previous practices, this functionality supports informed decision-making and continuous improvement strategies.

Cerexio EBR Manufacturing Software

Benefits of Cerexio EBR System

Cerexio EBR System is a pinnacle of technological advancement by seamlessly integrating various devices and instruments, automating the intricate data collection process from production cycles. This integration prevents the conventional need for manual paper-based recording. Operators routinely interface with diverse instruments within laboratory settings, producing critical process data encompassing sensor readings and QC outputs. The astute integration of Cerexio EBR System with these systems assures meticulous automation in data capture, drastically mitigating the potential for errors.

CALAO

This system has proven to maintain the five main characteristics of digital records, which are contemporary, accurate, legible, attributable, and original, thus ensuring the quality and high standard of SOP (Standard Operating Procedures).

 

Paperless to The Core

Cerexio EBR System exemplifies a paperless culture in your factory by digitising and streamlining batch record management. This system efficiently ensures a seamless transition to electronic batch records (EBRs) while enhancing data accuracy, accessibility, and compliance.


Adherence to Compliance

Cerexio is aware that 21 CFR Parts 210–211 regulations provide proof of completion for each major step; this covers the manufacturing, packaging, and storage of every medication batch. Therefore, our EBRs manufacturing solution enables you to comply with the policymakers and cGMPs and meet all requirements with ease.

Save on COQ

Cerexio EBR System streamlines and automates processes, resulting in significant savings that lower the Cost of Quality associated with batch record management. Errors are eliminated, real-time visibility is provided, compliance is guaranteed, and productivity is increased, all of which lead to more economical operations.

Pinpoint Illegal Values

Cerexio EBR System swiftly identifies and flags unauthorised or irregular values within the manufacturing process, enabling prompt action to rectify deviations. This feature ensures compliance and accuracy while maintaining the integrity of the production system.

Say No to Missing Values

It prevents data gaps by diligently detecting and addressing missing values within the manufacturing workflow. This feature ensures comprehensive and accurate documentation, reducing errors and maintaining the integrity of crucial production records.

Scribal Error-free

This solution guarantees error-free records by eliminating manual transcription errors commonly associated with traditional handwritten records. This feature ensures meticulous data accuracy, enhancing overall reliability and compliance within manufacturing processes.

Universal Industry Friendly

Cerexio EBR System can be used by all sorts of compliance-sensitive and Current Good Manufacturing Practice (CGMP) oriented industries like food, medical drugs, alcohol, drinks, pharmaceuticals and more.

The Single Source of Truth

Cerexio EBR System, exemplified by smart data optimisers, centralises accurate, comprehensive data storage in manufacturing EBRs, enabling authorised personnel to access data seamlessly from any location.

Full-Scale Compliance

With unrivalled experience in GMP, PIC/s, GAMP, and other compliance expertise across multiple continents, this software meets stringent regulatory requirements for health sciences, food, and drugs while adhering to top global standards, offering inclusive validation, qualifications, SOPs, and comprehensive quality documentation.

OEE Upheaval

This digital solution actively monitors manufacturing machinery to guarantee peak efficiency. It stops equipment use beyond predetermined calibration or maintenance schedules by monitoring and alerting deviations by optimally managing EBRs in manufacturing plants.

User-friendly Interface
Cerexio EBR System offers a user-friendly interface catering to diverse user needs, minimising errors, providing clear guidance, and fostering user satisfaction, loyalty, and a positive brand image for Quality in many industrial manufacturing domains.

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