Synapse
The cloud platform that turns raw sensor readings into audit-ready evidence. An immutable data layer preserves every measurement exactly as recorded, and read-only analytics produce compliance reports that hold up to scrutiny.
ALCOA+ CompliantAll nine ALCOA+ data-integrity principles satisfied.
MKT TraceabilityMean Kinetic Temperature via the Haynes formula, for any time window.
Automated ReportingBranded, tamper-proof Data Log and Error Log reports, generated automatically.
International ComplianceAligned with Swissmedic, EU GDP and Annex 11, and FDA 21 CFR Part 211.
Synapse specifications
Data integrity
- Architecture
- A strict separation between an immutable data layer and a read-only presentation layer
- Raw record
- Every raw measurement is stored exactly as recorded. The data layer is append-only and is never averaged, overwritten or deleted
- Transmission
- A CRC integrity check runs on every payload. Any transmission that fails is flagged and rejected
- Timestamping
- Each reading is timestamped on the device in UTC at the moment of capture
- Statistical envelope
- Each bucket retains the full Tukey five-number summary (min, Q1, median, Q3, max) plus the arithmetic mean and four timestamps
- Excursion priority
- A deterministic algorithm surfaces threshold breaches and sensor saturation as the displayed value instead of averaging them away
- Standard
- Satisfies all nine ALCOA+ principles
Mean Kinetic Temperature
- Method
- Mean Kinetic Temperature computed with the Haynes (1971) formula
- Activation energy
- Ea = 83.144 kJ/mol, per USP ⟨1150⟩
- Gas constant
- R = 8.3144 J·mol⁻¹·K⁻¹
- Windows
- Any interval computed on demand, e.g. 6 hours, 24 hours, 7 days or a full month
- Basis
- Computed from equidistant 5-minute samples with no interpolation, imputation or gap-filling
- Guidance
- Aligned with ICH Q1A(R2), USP ⟨1079.2⟩ and WHO TRS 961 Annex 9
Alerting and intelligence
- Channels
- Instant notifications by SMS, email and push
- Thresholds
- Adjustable upper and lower limits per measurement channel
- Early warning
- An AI early-warning architecture advises before conditions turn critical
- Audit trail
- An automated, tamper-proof audit trail records every environmental change on the premises
Reporting and compliance
- Reports
- Automated Data Log and Error Log reports, delivered as branded, tamper-proof PDFs
- Views
- A SensorValue line chart that highlights excursions, alongside a box-plot view of the full distribution
- Completeness
- Tiered data-completeness disclosure, with a Data Coverage Log listing every gap and its cause
- Retention
- Cloud storage with redundancy, backup and disaster recovery for the full regulatory retention period
- Frameworks
- EU GDP (2013/C 343/01)
- EU Annex 11
- FDA 21 CFR Part 211
- PIC/S PI 041-1
- ICH Q1A(R2)
- USP ⟨1079⟩ / ⟨1079.2⟩
- WHO TRS 961 Annex 9
- Swiss compliance
- Built around the Pharmacopoeia Helvetica hard limits with per-event out-of-specification assessment, and aligned with the GSASA recommendations and Swissmedic
Integration and access
- Infrastructure
- Integrates with the systems and protocols you already run
- Scalability
- Synapse scales as you add sites and sensors
- Data residency
- Swiss and EU data residency
- Remote access
- Reach any asset from phone, tablet or web browser
- Support
- A dedicated support team backs setup and day-to-day operation
See the audit write itself.
Twenty minutes on Synapse with your own data. We will show you excursions surfaced, MKT computed and a compliance report generated.