Complete Audit Trails. Built In.
Cleanroom monitoring, equipment validation tracking, and complete audit trails that hold up under FDA and EMA inspection.
Where audit trail gaps become 483 observations
Audit Trail Gaps Keep You Up at Night
Electronic records need complete audit trails. Any gap is a 483 observation waiting to happen. Your paper-based backup systems create more risk.
Warning letters and consent decrees
Cleanroom Contamination Is Invisible
Differential pressure dropped in Suite 4. For how long? Your BAS logged it, but correlating that with production records takes hours.
Batch rejection and investigation costs
Equipment Validation Is a Paper Mountain
IQ, OQ, PQ protocols. Change control documentation. Periodic review records. All scattered across systems that don't talk to each other.
Months of validation delays
Environmental Monitoring Is Manual
Particle counts, differential pressures, temperature, humidity. Each system has its own interface. Correlating excursions to batches is detective work.
Investigation time and batch holds
Before and after Sandhed
- ✕Paper logbooks with audit trail gaps
- ✕Manual environmental monitoring correlation
- ✕Validation docs in multiple systems
- ✕Batch investigations take weeks
- ✓Complete electronic audit trails
- ✓Real-time EM visualization in 3D
- ✓Unified validation status dashboard
- ✓Click batch, see all related events
Solutions Built for Pharmaceutical
Explore the specific solutions most relevant to your operations.
Numbers That Matter to Your P&L
Built for Pharmaceutical
Purpose-built features that address your industry's specific challenges.
Regulatory-Ready Audit Trails
Every action logged with who, what, when, and why. Electronic signatures and access controls that hold up under inspection.
GxP ready
Cleanroom Visualization
See differential pressure, particle counts, and environmental conditions for every suite in one 3D view.
Continuous monitoring
Equipment Validation Tracking
See IQ/OQ/PQ status, upcoming calibrations, and change control history for every asset in one place.
Complete lifecycle
Complete Audit Trails
Every action recorded with full context. Immutable records that auditors trust.
Zero gaps
Environmental Monitoring
Temperature, humidity, pressure, and particle counts all tied to the batches they affect. Excursions link to production records automatically.
Multi-parameter
Deviation Management
When something goes out of spec, the right people are alerted and affected batches are flagged automatically.
Instant correlation
A Day in the Life with Sandhed
Here's what a typical day looks like with Sandhed running.
Documenting a 47-second pressure drop automatically
Suite 3 differential pressure dropped below spec for 47 seconds during door access. Sandhed logged it with timestamp, linked it to the batch in production, and documented the rapid recovery. Your next FDA inspection? Zero observations on environmental monitoring.
3:42 AMPulling a complete batch audit trail on demand
FDA auditor requests audit trail for Batch 2024-0847. You pull up Sandhed, click the batch, show every environmental parameter, every equipment used, every user action, every electronic signature. Timestamped, correlated, complete. Complete, correlated, timestamped.
10:00 AMRunning an annual validation review in 30 minutes
Annual equipment validation review is due. Instead of pulling documents from 5 systems, you open Sandhed, filter by equipment type, export a complete validation status report with calibration history, change control log, and usage metrics.
2:00 PMConnects to Your GxP Ecosystem
Sandhed connects to your existing systems via industry-standard protocols.
- ✓Standard BMS protocols
- ✓Building automation systems
- ✓Standard LIMS integrations
- ✓Quality management systems
- ✓Standard serialization protocols
- ✓OPC UA
- ✓MQTT
- ✓REST API
See how Sandhed handles GxP compliance
See how Sandhed delivers complete audit trails while giving you real-time visibility into your entire GxP environment.