Advancing Data Integrity, Compliance, and Productivity for Rapid Microbial Methods
We understand the critical role software plays in the success of RMMs. Driven by our commitment to exceeding customer expectations, we are excited to unveil Celsis® Software version 5, a major upgrade for Celsis ATP-bioluminescence technology that goes beyond addressing standard human-error and subjectivity issues in RMMs.
Our Celsis Rapid Detection Software version 5 ensures regulatory compliance, automated results interpretation, and robust data integrity features, providing a complete user experience that prioritizes accuracy and efficiency. It also streamlines user workflow and experience, empowering users to make quality decisions and improve data management.
Explore the Celsis® Rapid Microbial Detection Brochure
Gain insight into Celsis® technologies, platform capabilities, implementation considerations, validation support, and microbial detection applications across a range of product types.
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Key Features and Benefits of Celsis® Software Version 5
Data Protection with Automatic Backup Processing
Microbiology testing facilities face significant data loss risks when relying on manual or less reliable backup methods. A reliable and automated backup process is crucial for protecting valuable assay results and data, ensuring data integrity, and facilitating compliance with regulatory requirements. Celsis Software version 5 addresses this challenge with an automated backup processing feature.
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Details
- Assay results and data are automatically backed up in a secure database
- Prevents potential data loss from manual or inefficient backup methods
- Boosts compliance with regulatory requirements, such as FDA 21 CFR Part 11 and Annex 11
- Facilitates easy access to data for auditing purposes
Streamlined Workflow for Enhanced Productivity
Version 5 optimizes the entire RMM workflow process, addressing common challenges faced with other RMMs, such as unclear instrument start-up procedures, cryptic error codes, and manual data entry. A refined workflow process should include clear instrument start-up procedures, detailed error code descriptions, and automated data entry capabilities to reduce manual intervention and minimize the risk of human error.
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Details
- Mandatory instrument start-up, daily control procedures before each run, ensuring proper setup and reducing invalid results
- Barcode scanner support for quick and accurate reagent and accessory database management, reducing manual entry errors
- Detailed error code descriptions for faster issue recognition and resolution, minimizing downtime
Strengthened Data Integrity with Enhanced Audit Trails
Audit trails are essential for maintaining data reliability and demonstrating compliance with regulatory standards. However, many quality control microbiology laboratories struggle with limited audit trail functionality in their RMM software, making it difficult to track important assay changes, search for specific entries, and understand the context of each event.
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Details
- Captures important assay changes for comprehensive modification records
- Provides easy navigation and search capabilities for quick entry location and trend identification
- Includes user-friendly descriptions for better context and event significance understanding
- Functional and designed for consistent user experience
Improved User Management for Advanced Security and Protection
Labs often struggle with vulnerabilities arising from separate login credentials and limited control over user roles and privileges, potentially compromising data accuracy and increasing the risk of unauthorized changes. Version 5 introduces advanced user management and digital signature features.
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Details
- Active directory integration for seamless, secure login with network credentials
- Customizable privilege groups for granular control over user access and permissions
- Multi-level user ID and digital signature capabilities for clear audit trails and authorization hierarchies
Complete Maintenance and Event Tracking
Many microbiology testing departments struggle with inadequate maintenance and event tracking capabilities in their software, leading to missed maintenance events, expired reagents, and difficulties in tracing data discrepancies. The new version of Celsis software introduces a complete maintenance and event tracking system to optimize instrument performance.
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Details
- Active reagent tracker display on the home screen for real-time visibility and proactive inventory management
- Alerts for required maintenance events, ensuring optimal instrument condition and performance
- New modules for performing and recording monthly and quarterly preventative maintenance
- Detailed audit trail logging of all reagent and event tracking information for comprehensive traceability
Enhanced Decision-Making with User-Friendly Reporting
Reporting is a critical aspect of RMM processes, as it provides the necessary information for making data-driven decisions and demonstrating compliance with regulatory requirements. Celsis Software Version 5 delivers a new, user-friendly reporting format that enhances decision-making for QC microbiology labs.
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Details
- Provides a consistent and familiar user experience across the Celsis product portfolio
- Users can easily navigate, interpret reports, and digitally sign reports regardless of which Celsis system they are using, which facilitates a seamless transition between different instruments
- Simplified report structure with all activities associated with a sample are logged for enhanced traceability
- Ensures a complete and accurate record of all data-related actions, facilitating efficient auditing
Refined Instrument Performance and Efficiency with Advanced Hardware Controls
Version 5 introduces enhanced hardware controls to boost instrument performance, reduce wear and tear, and improve overall productivity.
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Details
- Intelligent position movement control in Advance II™ and Accel® instruments, reducing wear and extending instrument lifespan
- Significantly reduced startup and daily control completion times for faster time-to-results and improved product release timelines
- Demonstrates a deep understanding of customer challenges and a commitment to delivering tangible value
Would you like to request an in-depth software demonstration and detailed guidance on the upgrade process?
Guidance on Implementation of Alternative RMMs
This Ebook addresses the technical, business, and data integrity issues in implementing ARMM technologies for the development, in-process control, and commercial release of drug products.
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