Dibatch - Digital Batch
DiBatch provides complete control over the Master Batch Record (MBR) lifecycle: configuration, review, approval, execution, final review, and electronic signature.
It enables a gradual approach to digitalization, starting from the most critical processes without the need to overhaul the entire production workflow.
Why choose Dibatch - Digital Batch Record
Start from what you already use
Import your Batch Records directly from Microsoft® Word files or other formats, maintaining the original layout and reducing impact on team.
Gradual implementation
Start using Dibatch immediately, configuring one Master Batch Record at a time. Add new objects to the library and validate them at any time.
Simple configuration
Set up Master Batch Records in 3 weeks (instead of 3 months), without writing code, thanks to an extensive library of ready-to-use objects: data, text, signatures, images... No IT skills required.
GxP Compliance
Complete audit trail, electronic signatures compliant with 21 CFR Part 11, versioning and profiled access. Validates as Category 4 software (according to GAMP 5.2).
Error reduction
Supports manual and automatic data entry (e.g., instrument readings, QR/barcode scanning, photos), plus integration via web services (e.g., ERP, LIMS), with real-time control of entered data.
Optimized review
The Review by Exception function allows you to focus only on critical data instead of examining all report data.
Key features
What can you manage with Dibatch – Digital Batch?
Master Batch Record lifecycle management
Configuration, review, approval with version control and validity date management.
Individual Batch Record lifecycle management
Execution, review and approval.
Manual and automatic data-entry
Fill records with manual or automatic inputs through data acquisition from barcodes/QR codes, photos, instruments and integrations via web services (ERP, LIMS, MES…)
Import from Word documents
Quickly digitize your Batch Records starting from Microsoft® Word documents already in use, maintaining the original layout.
Configurable object library
Leverage a complete set of no-code elements (QR codes, images, checklists, formulas, signatures...) to create dynamic MBRs.
Review by Exception
Reduce review time by focusing only on critical data and any anomalies detected by the system.
Want to see how the Dibatch software works to digitize Batch Records?
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Contact us for more information about the Bluenext Dibatch solution for Batch Record digitization, to schedule a free demo or to request a quote.
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