Scigeniq EBR is a complete Electronic Batch Records solution designed for growing life science companies to enhance compliance, reduce errors, and accelerate batch release.
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With Scigeniq Electronic Batch Records (EBR), your production team has a smarter, more efficient way to manage batch documentation. Reduce errors, accelerate batch release, and ensure compliance from day one.
Effortlessly meet GMP requirements and regulatory standards (e.g., 21 CFR Part 11). Our system ensures consistent adherence through secure, auditable, and tamper-proof digital records.
21 CFR Part 11 compliance built in.
Audit trails and change control fully automated.
Pre-validated system reduces implementation effort and validation time.
Say goodbye to costly manual entry mistakes and procedural slip-ups. Predefined workflows guide operators, while real-time controls enforce accuracy at every step.
Guided workflows walk operators through each step.
Role-based access and electronic signatures ensure only authorized actions.
In-process checks detect issues early, before they escalate.
Slash the time from production to release. Automated documentation, built-in checks, and a streamlined “Review by Exception” process significantly speed up batch review cycles.
Real-time data capture ensures instant documentation as production happens.
Automatic validations and checks reduce review cycles.
Integrated deviation and exception tracking eliminates delays.
Replace complex, error-prone paper processes. Capture critical manufacturing data automatically and in real-time directly from the source, ensuring your records are always precise.
Configurable templates simplify batch record setup.
Mobile-friendly design lets teams capture data on the floor.
Searchable digital records eliminate paper clutter and speed up audits.
Built to streamline your processes, these features power every step from batch start to release.
Provide managers with clear insights into Work-in-Progress (WIP) and key production metrics for continuous improvement.
Easily update, track and manage production tasks using an easy-to-use interface optimized for touch screens and support for multiple languages, including Arabic, English, and Portuguese.
Monitor the production process, issue warnings, and use a “Review by Exception” model to flag deviations needing scrutiny.
Integrate smoothly with Scigeniq Quality Management System, simplifying deviation investigations and change control.
Capture detailed execution data vital for validation, process replication, and scaling operations across sites or into commercial production.
Fully equipped with e-signatures, a complete audit trail, and secure role-based access to meet strict regulatory demands.
