Complete Audit Trails.Built In.
Cleanroom monitoring, equipment validation tracking, and complete audit trails 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
Solutions Built for Pharmaceutical
Explore the specific solutions most relevant to your operations.
Temperature Monitoring
A 2-degree drift in a freezer or pasteurizer can destroy product, trigger recalls, and halt production. Sandhed maps live temperature data from Shelly sensors onto your 3D floor plan so you see every cold chain risk the moment it starts.
View SolutionCompliance & Audit Trails
Most facilities piece together audit documentation from spreadsheets, paper logs, and disconnected systems. Sandhed records every action, threshold breach, and maintenance event automatically, so your compliance evidence is ready before anyone asks for it.
View SolutionMaintenance Management
Maintenance teams lose hours tracking down service records, chasing overdue tasks, and figuring out what was done last time. Sandhed puts every work order, service record, and maintenance schedule on your 3D floor plan where you can see it.
View SolutionEnvironmental Monitoring
Humidity creeping up in a cleanroom or pressure dropping in a controlled area can compromise an entire production run. Sandhed puts live environmental data from every sensor onto your 3D floor plan so you catch problems the moment conditions change.
View SolutionFloor Plan Visualization
Upload a floor plan and get an interactive 3D model of your facility in hours. Place assets, define zones, and overlay live sensor data on your actual building layout.
View SolutionAI Operations Assistant
Type a question about your facility and get answers grounded in real sensor data. Sandhed's AI assistant queries your equipment metrics, alerts, and maintenance records to give you plain-language answers instead of dashboards to decipher.
View SolutionWork Order Management
A broken machine gets reported verbally. A work order gets scribbled on paper. No one knows who is handling it or when it will be done. Sandhed gives every work order a location, an owner, and a timeline.
View SolutionHistorical Replay & Incident Investigation
When something goes wrong on the floor, the first question is always 'what happened?' Sandhed's Timemachine lets you scrub back to any moment and see your entire facility exactly as it was.
View SolutionUniversal Integration
Your PLCs, sensors, RTLS tags, and warehouse systems all generate data. Sandhed connects to all of them through a unified pipeline and brings everything onto one floor plan.
View SolutionProven Results
Numbers That Matter to Your P&L
Audit trail coverage
Faster investigations
Faster validation cycles
Setup time (not months)
Based on platform capabilities and industry benchmarks.
Capabilities
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.
Cleanroom Visualization
See differential pressure, particle counts, and environmental conditions for every suite in one 3D view.
Equipment Validation Tracking
See IQ/OQ/PQ status, upcoming calibrations, and change control history for every asset in one place.
Complete Audit Trails
Every action recorded with full context. Immutable records that auditors trust.
Environmental Monitoring
Temperature, humidity, pressure, and particle counts all tied to the batches they affect. Excursions link to production records automatically.
Deviation Management
When something goes out of spec, the right people are alerted and affected batches are flagged automatically.
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
Related Resources
Why Does My Production Line Keep Stopping?
Most unplanned stops come from a short list of causes that compound each other. Sensor blind spots, delayed maintenance response, equipment running past rated cycles, power quality events, raw material drift, PLC faults, and shift-change errors account for the majority of lost production time. Fixing them requires data correlation, not more dashboards.
Read answerHow to Reduce Equipment Downtime: 8 Strategies Ranked by Impact
Reducing equipment downtime starts with knowing where you're losing time, not with buying technology. The eight strategies below are ranked by how much downtime they typically eliminate in the first year. The top three are organizational fixes that cost almost nothing. The rest require incremental investment but build on each other.
Read answerSee how Sandhed handles GxP compliance
See how Sandhed delivers complete audit trails while giving you real-time visibility into your entire GxP environment.
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