Complete Audit Trails.Built In.
Cleanroom monitoring, equipment validation tracking, and complete audit trails that that hold up under FDA and EMA inspection.
The Challenge
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.
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.
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.
Environmental Monitoring Is Manual
Particle counts, differential pressures, temperature, humidity. Each system has its own interface. Correlating excursions to batches is detective work.
The Difference
Before and after Sandhed
Before
Paper logbooks with audit trail gaps
With Sandhed
Complete electronic audit trails
Before
Manual environmental monitoring correlation
With Sandhed
Real-time EM visualization in 3D
Before
Validation docs in multiple systems
With Sandhed
Unified validation status dashboard
Before
Batch investigations take weeks
With Sandhed
Click batch, see all related events
Capabilities
Built for Pharmaceutical
Purpose-built features that address your industry's specific challenges.
Regulatory-Ready Audit Trails
Electronic signatures, audit trails, and access controls that support regulatory requirements.
Cleanroom Visualization
Real-time differential pressure, particle counts, and environmental data in 3D.
Equipment Validation Tracking
IQ/OQ/PQ status, calibration due dates, and change control history per asset.
Complete Audit Trails
Who, what, when, and why for every action. Immutable and tamper-evident.
Environmental Monitoring
Temperature, humidity, pressure, and particle counts correlated to batches.
Deviation Management
Excursions trigger alerts and automatically link to affected batches and lots.
Proven Results
Numbers That Matter to Your P&L
Audit trail compliance
Investigation closure
Validation lifecycle tracking
Setup time (not months)
Based on platform capabilities and industry benchmarks.
Real-World Scenarios
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.”
Pulling 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.”
Running 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.”
Integrations
Connects to Your GxP Ecosystem
Sandhed connects to your existing systems via industry-standard protocols.
BMS/EMS
LIMS
QMS
Serialization
Protocols
Don't see your system? We support 150+ industrial protocols via our gateway integrations.
Success Story
Real Results from Real Operations
“Our audit trails are now our strongest asset, not our biggest vulnerability. Inspections have become much smoother.”
Company Type
Sterile Injectable Manufacturer
Employees
650
Cleanroom suites
24 suites
Improved
FDA inspection outcomes
Faster
deviation investigations
Full
validation lifecycle tracking
See how Sandhed handles GxP compliance
See how Sandhed delivers complete audit trails while giving you real-time visibility into your entire GxP environment.
Free pilot available. No credit card required. Cancel anytime.