Compliance without the complexity
GDP, GMP, and ISO 13485 made practical
Validated systems typically cost millions and take years to implement. AmpliFlow Box gives you temperature monitoring, batch labeling, and sample tracking with plug-and-play simplicity. Full audit trail for regulatory inspections.
For pharmaceutical, medical device, and biotech companies that need practical compliance solutions.
Compliance shouldn't require a validation project
GDP, GMP, and ISO 13485 require documented controls and complete traceability. Traditional solutions are expensive, complex, and take months to implement.
Temperature excursions go undetected
GDP requires documented temperature during storage and transport. Manual logging is error-prone and deviations are discovered too late.
Batch traceability gaps
GMP requires every product to be traceable to its production record. Manual labeling creates gaps that auditors find.
Sample chain of custody
Clinical samples and lab specimens need documented tracking through every step. Paper logs don't scale.
Validated systems cost millions
Traditional MES, LIMS, and cold chain systems require extensive IT validation projects, dedicated infrastructure, and ongoing maintenance.
Practical compliance for life science
AmpliFlow Box connects your quality system to the physical world. Automatic temperature logging, batch labeling triggered by checklist completion, and sample tracking with full audit trail.
GDP temperature monitoring
Sensors connected to AmpliFlow Box log continuously. Automatic alerts when temperature deviates. Full audit trail for regulatory inspection.
Batch and lot labeling
Checklist completion triggers label printing with batch number, expiry date, and barcode. Links production record to physical product automatically.
Sample tracking
Print labels when samples are registered. Scannable barcode tracks chain of custody through every process step.
Equipment labeling
Calibration status labels, cleaning verification labels, and maintenance due labels. All linked to your equipment records.
Audit trail for 21 CFR Part 11
Every action logged with timestamp, user, and reason. Electronic records that support FDA compliance requirements.
Plug-and-play deployment
No IT validation project. Connect to network, pair with AmpliFlow, start using. Device swap if failure means no downtime.
Built for life science workflows
AmpliFlow Box supports the specific needs of pharmaceutical, medical device, and biotech operations.
"AmpliFlow, which understands both management systems and IT, is a perfect partner. They have helped us with a smooth and logical structure with exactly the IT tools needed to pass a certification audit."
Built for life science regulations
AmpliFlow Box helps you meet requirements that previously required expensive validated systems. Connect quality processes to physical controls with complete traceability.
GDP Compliance
Good Distribution Practice requires temperature monitoring and documentation. AmpliFlow Box logs continuously with automatic deviation alerts.
GMP Documentation
Good Manufacturing Practice batch records linked to physical labels. Complete traceability from production to product.
ISO 13485
Medical device quality management with documented controls and traceability requirements.
Deviation Handling
Temperature excursions and process deviations automatically create deviation records for investigation.
Questions about AmpliFlow Box for life science
Answers to common questions about deployment and compliance.
Does AmpliFlow Box require IT validation?
AmpliFlow Box is designed for operational simplicity. We provide documentation to support your qualification activities, but the device itself doesn't require the extensive validation projects typical of enterprise systems. It's a controlled device that logs data to AmpliFlow's validated cloud infrastructure.
How does it support FDA 21 CFR Part 11?
AmpliFlow maintains audit trails with user identification and timestamps for changes. Checklist completions that trigger label printing are automatically logged with who completed them and when. Your qualification documentation can reference these controls.
What sensors are supported for temperature monitoring?
We support standard temperature probes via USB and wireless sensors. Contact us for specific sensor compatibility. The system logs readings at configurable intervals with deviation alerting.
Can we use existing label printers?
AmpliFlow Box supports Brother QL series and Honeywell ZPL printers. For other printers, contact us to evaluate compatibility. Most industrial label printers with standard protocols can be integrated.
What happens if the device fails?
We ship a replacement device that you simply connect and pair. Your configuration is stored in AmpliFlow, so the new device picks up where the old one left off. No data loss, minimal downtime.
How long does implementation take?
From unboxing to first use typically takes 15-30 minutes per device. Configuration of label templates and checklist triggers can be done in AmpliFlow without any on-site work. Most implementations are complete within days, not months.
Have questions about your specific compliance needs?
We're happy to discuss how AmpliFlow Box fits your regulatory environment.
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Guides and articles about practical compliance for pharmaceutical, medical device, and biotech companies.
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Book a demo and we'll show you how AmpliFlow Box can simplify your GDP temperature monitoring, GMP batch labeling, and sample tracking. No million-dollar validation project required.