Cerexio EBR System: Electronic Batch Record System
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.
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
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 do you need the Cerexio EBR System?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Our Experts Ready to Help You
How does the Cerexio EBR System improve digital record management?
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.
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.
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.
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.
Benefits of Cerexio EBR System
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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