For lab operators · QA · Operations · IT · Procurement
Real-time instrument health monitoring, drift and threshold alerts, and traceable records your team can export for review — without replacing your validated equipment.
Whether you're managing compliance across analytical, QC, or environmental instruments, Trucision gives your operations team visibility to flag drift and anomalies early enough to schedule service or review, and documentation to support your response when auditors ask.
Supports your compliance with:
21 CFR Part 11
EU Annex 11
Health Canada GUI-0050
ISO 13485 / MDSAP
ISO/IEC 17025
GMP / GLP
SOC 2 Type II
built for your whole team
Trucision's AI connects to your instruments, LIMS and quality systems with read-only access. It never changes your data. It gathers what your team needs, shows where every fact came from, and your people review and sign off. Here's what each team gets.
OOS investigations, audit trail gaps, and calibration failures — discovered by your auditor before your team.
Structured deviation context — timestamped, sensor-anchored, ready for quality system review
Traceable records for every instrument event — structured for your quality system export
Calibration drift alerts 48–72 hours before instruments cross a compliance threshold
Inspection-ready dashboards — give the auditor a URL, not a binder
48–72 hour advance notice when telemetry crosses your configured control limits — suspect drift or component stress, not a confirmed failure
Shared telemetry package sent to your service team before dispatch — reducing repeat visits and guesswork
Condition-based maintenance scheduling replaces fixed-interval guesswork
Utilization data to justify instrument investment — and flag what’s being underused
Every instrument vendor has a different data format. your LIMS doesn’t know the instrument’s health state. and IoT devices create security exposure.
MQTT and REST integration with LIS — no proprietary protocol lock-in
Pre-built connectors for major LIMS, ELN, and cloud data platforms
Works in air-gapped and restricted-network environments with on-device buffering
Role-based access control, immutable audit logs, SOC 2 Type II
Fixed service contracts don’t reflect actual usage. emergency calls are expensive. you have no data to negotiate from at renewal.
Utilization and failure mode data to negotiate your next service contract from evidence, not estimates
Your own visibility into service SLA performance — your operational data alongside your vendor’s reporting
Condition-based service models replace flat annual fees
Before/after service cost baseline — quantify ROI for leadership
key outcomes — for your lab
Early warning window
When telemetry crosses your configured thresholds — before a service action is typically required.
Fewer reactive calls
Condition-based monitoring allows labs to replace fixed-interval PM schedules.
Remote pre-diagnosis rate
Of instrument service cases begin remote diagnosis — reducing average time-to-dispatch and improving first-visit resolution rates.
Time to first alert
From instrument connection to first instrument health alert — including telemetry schema setup and first model deployment.
your industry, your compliance framework
Select your industry to see how Trucision maps to your specific compliance environment, instrument types, and risk profile.
21 CFR Part 11 • 21 CFR Part 211 • EU GMP Annex 11 8 • ICH Q10 • ALCOA+
HPLC and LC/MS systems
Gas chromatographs (GC)
UV/VIS and IR spectrophotometers
Dissolution testers
pH meters and karl Fischer titrators
Environmental monitoring sensors (temperature, humidity, particle counts)
Calibration drift found during batch release testing — batch hold, OOS investigation, potential rejection
OOS result caused by instrument failure, not sample failure — investigation, regulatory reporting obligation
Audit trail gaps in electronic records — FDA Form 483 observation, warning letter risk
Fixed-interval calibration misses drift between cycles — instruments used out-of-spec without anyone knowing
ISO 13485 • 21 CFR Part 820 • EU MDR/IVDR • ISO 9001
Tensile and compression testers
Coordinate measuring machines (CMM)
Particle counters and cleanroom monitoring systems
Hardness testers
Surface roughness and optical profilometers
Environmental monitoring sensors
Instrument failure during a production run — DHR gap on all parts produced during that window
IQ/OQ/PQ documentation manually maintained — recertification is expensive, slow, and error-prone
Cleanroom environmental excursion not caught in real time — batch quarantine, corrective action, potential recall
CAPA records created reactively with incomplete instrument context — investigation takes longer, findings are weaker
outcome 1
Drift and threshold alerts notify your QA team before instruments go out of spec — not after a failed QC sample identifies the problem.
outcome 2
Every instrument event generates a traceable record: instrument ID, operator identity, timestamp, and environmental conditions — structured for your quality system export. Tamper-evident by design.
outcome 3
When an OOS result occurs, trucision provides the instrument health history for the preceding 72 hours — the first thing an investigator needs and the thing that typically takes two days to reconstruct manually.
fda fsma • iso 22000 • haccp • sqf • brc global standards
Moisture and water activity analyzers
Near-infrared (NIR) analyzers
Texture analyzers and rheometers
pH meters and titrators
Checkweighers and X-ray inspection systems
Environmental monitoring sensors
Instrument failure at a HACCP critical control point — line stop, potential product hold or recall risk
Calibration drift in moisture or NIR analyzers — incorrect QC results — shelf-life or food safety risk
Manual calibration logs fail FSMA supplier verification audit — corrective action required, audit finding on record
Emergency service call during peak season — 2–5 day wait for a field technician
outcome 1
Drift and threshold alerts notify your QA team before instruments go out of spec — not after a failed QC sample identifies the problem.
outcome 2
Every instrument event generates a traceable record: instrument ID, operator identity, timestamp, and environmental conditions — structured for your quality system export. Tamper-evident by design.
outcome 3
When an OOS result occurs, trucision provides the instrument health history for the preceding 72 hours — the first thing an investigator needs and the thing that typically takes two days to reconstruct manually.
iso 17025 • a2la accreditation • nelap / tni standard • nelap / tni standard
ICP-MS and ICP-OES systems
GC/MS and GC-FID systems
TOC analyzers
Ion chromatographs
Atomic absorption spectrometers
Flow injection analyzers
Instrument drift between QC sample runs — client sample results affected before drift is formally detected
Accreditation renewal: manually maintained equipment logs — auditor findings, potential scope reduction
Turnaround time pressure: instrument downtime during hold-time sample window — sample invalidation
Matrix interference or detector degradation between calibration cycles — not caught until QC fails
Drift and threshold alerts notify your QA team before instruments go out of spec — not after a failed QC sample identifies the problem.
Every instrument event generates a traceable record: instrument ID, operator identity, timestamp, and environmental conditions — structured for your quality system export. Tamper-evident by design.
When an OOS result occurs, trucision provides the instrument health history for the preceding 72 hours — the first thing an investigator needs and the thing that typically takes two days to reconstruct manually.
OSHA PSM • API Standards • ATEX / IECEx • ISO 9001 / ISO/IEC 80079
Process gas chromatographs (process GC)
Viscometers and rheometers
Karl Fischer water content analyzers
Flash point and distillation testers
Online and at-line NIR and Raman analyzers
ATEX-rated process analyzers in classified areas
Process GC downtime in a refinery — quality decisions made without analytical data — process safety risk or specification failure at product transfer
ATEX instrument failure in a hazardous classified area — field service entry requires confined-space protocols — days of delay before diagnosis
Fixed PM schedule misses actual degradation — instrument fails between planned maintenance visits
Without remote pre-diagnosis data, dispatch occurs without confirmed root cause — increasing second-visit rates and the time before the right part is on site
outcome 1
Drift and threshold alerts notify your QA team before instruments go out of spec — not after a failed QC sample identifies the problem.
outcome 2
Every instrument event generates a traceable record: instrument ID, operator identity, timestamp, and environmental conditions — structured for your quality system export. Tamper-evident by design.
outcome 3
When an OOS result occurs, trucision provides the instrument health history for the preceding 72 hours — the first thing an investigator needs and the thing that typically takes two days to reconstruct manually.
GLP (21 CFR Part 58) • ISO 17025 • OECD GLP • Sponsor-specific SOPs
Multi-vendor analytical fleets (HPLC, GC, LC/MS, ICP) across mixed generations and data formats
Stability chambers and environmental monitoring systems
Dissolution and disintegration testers
Spectrophotometers (UV/Vis, FTIR, Raman)
Online and at-line NIR and Raman analyzers
Sponsor audit finds instrument qualification gap — study data challenged — repeat testing cost and client relationship damage
Multi-OEM fleet: each vendor's data format and service portal — no unified instrument health view across the lab
Instrument failure during a GLP study — study integrity question — sponsor notification required under GLP regulations
Utilization imbalance: some instruments chronically overloaded, others underused — billing inefficiency and accelerated wear
outcome 1
Drift and threshold alerts notify your QA team before instruments go out of spec — not after a failed QC sample identifies the problem.
outcome 2
Every instrument event generates a traceable record: instrument ID, operator identity, timestamp, and environmental conditions — structured for your quality system export. Tamper-evident by design.
outcome 3
When an OOS result occurs, trucision provides the instrument health history for the preceding 72 hours — the first thing an investigator needs and the thing that typically takes two days to reconstruct manually.
platform capabilities
Ranges below reflect outcomes reported by lab operators and modeled across instrument portfolios in production use. Individual results depend on fleet size, instrument type, and current maintenance practice.
See the operational state of every connected instrument in real time — cycle counts, error codes, environmental readings, and health scores. Know before your team does when something is about to go wrong.
Trucision models calibration drift from real usage data, not fixed-interval schedules. Your QA team receives an alert 48–72 hours before an instrument crosses a compliance threshold — not after a failed QC sample triggers the investigation.
Every instrument event generates a structured record — timestamped, operator-attributed, and sensor-anchored. When an auditor asks for instrument history on a specific batch date, you pull a dashboard filter, not a binder.
When an instrument alerts, your service team sees the same telemetry you do — reducing back-and-forth before the right technician arrives with the right parts.
better together
Trucision doesn't replace your instruments or your OEM service relationship. It gives both sides the same real-time diagnostic picture — so when something needs attention, everyone already knows what it is.
The instruments you've already purchased, qualified, and validated — HPLC systems, GCs, dissolution testers, process analyzers — don't need to be replaced or upgraded. Trucision's lightweight edge agent connects to what you have, reading instrument health data without modifying anything your QA team has validated.
Works on instruments purchased 3, 5, or 10 years ago
No firmware changes, no hardware modification, no re-qualification trigger
Connects to your existing LIMS and data infrastructure — no parallel system to maintain-based maintenance scheduling replaces fixed-interval guesswork
When your instrument alerts, your service contact sees the same diagnostic data you do — in real time. That means when a technician is dispatched, they arrive with a confirmed diagnosis, the right parts, and a resolution plan. Fewer second visits. Faster resolution. A service relationship that works the way it was supposed to.
Shared diagnostic dashboard — your team and your service contact, same data
Service calls start with shared telemetry summary before dispatch, not a symptom description alone
Service calls start with shared telemetry summary before dispatch, not a symptom description alone
data integrity & compliance
ALCOA+ means every data point must be Attributable, Legible, Contemporaneous, Original, and Accurate. Trucision structures records at the instrument layer — giving your QA team the provenance they need when a question arises.
From Instrument to Audit Trail
Every measurement carries its provenance: instrument serial number, calibration state at time of reading, operator ID, environmental conditions, and a structured timestamp — for export and review in your quality system.
21 cfr part 11 and eu annex 11 ready
Electronic records are generated at the source, not transcribed from paper logs. Electronic signatures are linked to authentic user identities. Audit trails are system- generated and cannot be modified - meeting FDA and EU GMP requirements for computerized systems in regulated environments.
Deviation context, prepared for review
When a deviation occurs, Trucision prepares a structured context package: the triggering event, instrument sensor history for the preceding window, operator actions, and relevant calibration state — for your quality team to review, supplement, and sign off in your quality system.
An integration playbook designed for OEM engineering and service teams - not a SaaS rip-and - replace.
STEP 01
We review your instrument list, OS environments, and network architecture. We identify which instruments are connectable today and whether any require a gateway device. No site visit required for the initial scoping — this happens remotely.
STEP 02
Structured telemetry flows securely overMQTT or REST with TLS encryption-including in air-gapped or low-connectivity environments. Un-device buffering ensuresno data loss during network interruptions.
No re-validation of the instrument itself. The agent observes; it does not modify your validated state.
STEP 03
Data flows into your existing LIMS, ELN, orYour instrument's data schema is mapped, telemetry flows into the dashboard, and alert thresholds are set based on your QA team's specifications. First predictive health dashboard is live within two weeks of kickoff.
STEP 04
Your team has continuous visibility. Your QA lead gets structured compliance documentation ready for review. Your service contact gets telemetry context when something alerts. The system learns your instrument's operational baseline over time.
from the field
This is going to do wonders for their service technicians. Instead of guessing, they can use this platform, see the key diagnostics explained by evidence from full error history, and immediately understand what's going on.
- Lab Manager
US Lab Network
- SVP Procurement,
US Lab Network
Get started
We'll show you what your instrument data looks like in a Trucision dashboard — using telemetry patterns from instruments like yours. No commitment. One hour.
Instrument intelligence for regulated labs. Real-time health monitoring, structured deviation records, and exportable evidence for your audits — without replacing your instruments.
BUILT FOR REGULATED LAB OPERATIONS
