Compliance & Audit

Stop Scrambling Whenthe Auditor Walks In

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.

The Problem

Where Things Break Down

Regulated manufacturers spend weeks preparing for audits. Maintenance records are scattered across binders, CMMS exports, and email threads. When an auditor asks for proof that a temperature excursion was handled within your SOP window, someone has to dig through three systems to reconstruct the timeline. If the documentation is incomplete, the finding goes on your record regardless of whether the work was actually done.

Audit prep takes weeks, not hours

Your quality team spends 2-4 weeks before each audit gathering maintenance logs, calibration records, and corrective action documentation from separate systems. Every minute spent reconstructing records is a minute not spent on actual quality work.

80-120 hours of manual documentation assembly per audit

Paper-based records have gaps

Handwritten logs get lost, skipped, or filled in after the fact. When an auditor finds a missing entry, there is no way to prove the work was done. A single documentation gap can trigger a formal finding.

23% of FDA warning letters cite documentation failures

No connection between events and responses

A temperature alarm fired at 2:14 AM. Was it acknowledged? By whom? What corrective action was taken? Answering these questions means cross-referencing alarm logs, maintenance records, and shift notes from different systems.

Disconnected records that cannot prove timely response

Our Approach

What Sandhed Does Differently

Sandhed logs 78 distinct action types automatically, from user logins to threshold breaches to service record completions. Every entry is timestamped with the user, IP address, and affected resource. Because sensor data, maintenance records, and user actions all live in one platform, your audit trail connects the event, the response, and the outcome in a single searchable log. Export filtered reports by date range, action type, or resource for any audit period.

Automatic Action Logging

Every user action, alert acknowledgment, threshold change, and service record completion is logged with a timestamp, user identity, IP address, and resource context. No manual data entry required.

Exportable Audit Reports

Filter the audit log by date range, action type, user, or resource. Export up to 1,000 entries per report for regulatory submissions or internal reviews.

Service Record Documentation

Each maintenance event captures the checklist completion state, technician identity, parts used, costs, outcome (pass/fail/needs follow-up), and attached documents like certificates and inspection reports.

Role-Based Access Controls

Four-tier permission system (superadmin, admin, manager, viewer) with per-site access levels. Every permission grant and revocation is logged, creating a complete access history for security audits.

Quick Assessment

How Exposed Is Your Facility?

Compliance Readiness Assessment

Answer 5 questions to get a personalized score and recommendations.

How do you currently document maintenance activities for compliance?
How long does it take your team to prepare documentation for a regulatory audit?
Can you trace a sensor alarm back to the corrective action taken?

Industry Applications

Built for Your Industry

Compliance & Audit Trails for Pharma

Automatic audit logging for FDA-regulated environments. Every calibration, temperature excursion response, and maintenance completion documented with timestamped user attribution.

Pharmaceutical

Compliance & Audit Trails for Food & Beverage

HACCP-ready documentation with automatic logging of temperature monitoring, sanitation records, and corrective actions. Every critical control point event is timestamped and traceable.

Food & Beverage

Expected Outcomes

Results You Can Measure

0%

Less audit prep time

Reduction in manual documentation assembly

0

Action types logged

Distinct events tracked automatically

0%

Traceability coverage

Every user action and system event recorded

0 hrs

Setup time

From floor plan to live audit logging

Based on platform capabilities and industry benchmarks. Results vary by facility.

FAQ

Common Questions

Sandhed provides the technical controls that support 21 CFR Part 11 readiness: unique user identification, role-based access controls, timestamped audit trails for every action, and electronic records that cannot be modified after creation. The audit log captures who did what, when, and from which IP address. You still need your own procedural SOPs and validation documentation, but the platform provides the underlying technical infrastructure.

Related Solutions

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 Solution

Environmental 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 Solution

Quality Gate Monitoring

Quality gates catch bad parts, but they do not tell you why a station started failing. Sandhed maps pass/fail rates and SPC data to your 3D floor plan so you can trace defect patterns back to the source station in minutes, not days.

View Solution

See Your Audit Trail in Action

We will model your actual floor plan and show you how Sandhed logs every action, alert, and maintenance event for your specific regulatory requirements. No generic demo.