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.
The Problem
Where Things Break Down
FDA auditors expect instant traceability
When an FDA inspector asks to see the response chain for a temperature excursion on Reactor 3 from last Tuesday, your team cannot spend 30 minutes searching. The expectation is documented, timestamped, and attributable records available on demand.
GMP documentation requires continuous proof
Good Manufacturing Practice is not a one-time certification. Every batch, every maintenance event, and every deviation needs documented evidence that procedures were followed. Gaps in that documentation chain risk warning letters.
Electronic records need technical controls
21 CFR Part 11 requires unique user identification, access controls, and audit trails for electronic records. If your systems use shared logins or lack change tracking, the electronic records they produce may not satisfy regulatory requirements.
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.
Expected Outcomes
Results You Can Measure
Less audit prep time
Reduction in manual documentation assembly
Action types logged
Distinct events tracked automatically
Traceability coverage
Every user action and system event recorded
Setup time
From floor plan to live audit logging
Based on platform capabilities and industry benchmarks. Results vary by facility.
FAQ
Common Questions
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 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 SolutionQuality 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 SolutionSee 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.