Digital Batch Execution for GxP-Regulated Manufacturing
Next Plus replaces paper batch records with compliant digital eBR, automates deviation management, and ensures data integrity from first step to batch release.
Faster Batch Records
Fewer Deviations
GxP Compliant
Audit Time Saved
Industry Challenges We Solve
Pharmaceutical and biotech manufacturing demands perfect documentation, zero data integrity gaps, and full regulatory compliance at every step.
GxP & GMP Compliance
Maintain a complete and compliant quality system across batch execution, documentation, and personnel qualification.
Electronic Batch Records
Replace paper batch records with digital eBR that captures data automatically, enforces step completion, and requires e-signatures.
Deviation Management
Detect, log, and investigate deviations in real time. Route for review and link to CAPA workflows automatically.
Data Integrity (ALCOA+)
Ensure all data is Attributable, Legible, Contemporaneous, Original, and Accurate — with full audit trails to prove it.
Change Control
Manage SOPs, master batch records, and process changes with controlled approval workflows and instant roll-out to operators.
Operator Training & Qualification
Track training records and ensure only qualified personnel execute critical batch steps — enforced at the system level.
How Next Plus Helps
Purpose-built solutions for aerospace and defense manufacturing excellence
Electronic Batch Records (eBR)
Digitize your master batch record and execute it on the floor. Every weighing, mixing step, and in-process check is captured automatically — with the right signature at the right time.
- Digital execution of master batch records
- 21 CFR Part 11 / EU Annex 11 e-signatures
- In-process parameter capture and limit checks
- Automatic eBR generation — no manual assembly
Deviation & CAPA Management
When something goes outside spec, Next Plus catches it, routes it, and tracks it — from detection through root cause analysis and verified CAPA closure.
- Real-time deviation detection and logging
- Configurable review and approval workflows
- Root cause analysis tools built in
- CAPA tracking with evidence and closure verification
Built for Pharma & Biotech Compliance
From clinical manufacturing to commercial-scale production, Next Plus meets the documentation and quality requirements of the most regulated industry on earth.
Audit Trail
Every record change, signature, and review timestamped and immutable.
e-Signatures
FDA 21 CFR Part 11 and EU Annex 11 compliant with full authentication.
Data Integrity
ALCOA+ principles enforced by design — not by policy alone.
Validated Cloud
Pre-validated SaaS deployment with IQ/OQ documentation available.
Ready to Digitize Your Batch Operations?
See how Next Plus accelerates batch record completion while keeping you fully compliant. פשוט
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