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🔬 Labs · ISO/IEC 17025 · Biotech · Research · Traceability

Environmental Monitoring for Labs & Research

Data without traceability
does not hold up in an audit.
And without traceability,
accreditation is at risk.

In laboratories, the quality of environmental data is as critical as the data itself. Continuous monitoring with a calibration certificate, up to 5 years of history and per-device traceability, for audits, accreditations and scientific publications.

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COMPLIANCE
Testing labs, ISO standards and ISO/IEC 17025 accreditation
Pharmaceutical, R&D and production under GxP / FDA 21 CFR Part 11
Biotech, bioreactors, chambers and incubators
Academic, universities and research institutes
Calibration, ISO/IEC 17025 accredited labs
⚠ What is at stake without traceability

Undocumented environmental conditions
invalidate the result,
and the laboratory that produced it.

A test run at a temperature outside the specified range is an invalid test. A growth chamber that drifted overnight compromises the reproducibility of the experiment. An accredited laboratory that does not continuously monitor its environmental conditions is operating at risk of losing its accreditation.

The problem is not the environmental variation, it is having no record of it. With the data, you document, justify and defend. Without it, any audit can question the integrity of every result produced in the period.

For regulators, for accredited calibration laboratories (ISO/IEC 17025, ILAC-MRA) and for the editorial committee of any peer-reviewed journal, the traceability of environmental conditions is a validity criterion, not a formality.

🏛️

Loss of accreditation

ISO/IEC 17025 accredited or certified laboratories must demonstrate continuous control of environmental conditions, or they become subject to suspension of accreditation.

🧬

Results challenged in an audit

Without a history of environmental conditions during the test period, the auditor may question the validity of every result produced, with retroactive impact.

💉

Test invalidated by environmental variation

Biotech and pharma: temperature variation in bioreactors or growth chambers during the test compromises reproducibility and may invalidate the batch.

📚

Scientific reproducibility compromised

In academic research, the absence of environmental data makes it harder for other groups to reproduce the experiment, affecting the credibility of the publication.

🎯 Where PLEXOR operates

Every laboratory has
its own specific requirement.

From accredited calibration labs to biotech, every segment has its own traceability criterion. PLEXOR covers them all with calibratable hardware and a platform with up to 5 years of history.

🔬

Analysis and Testing Laboratories

Continuous environmental control with the traceability required by ISO 17025. History exportable for accreditation audits and the defense of results.

ISO 17025 up to 5 years Calibration
⚖️

ISO/IEC 17025 Accredited Labs

Accredited calibration laboratories must control the environmental conditions of the laboratory itself, and document them with metrological traceability.

ISO/IEC 17025 Calibration Traceability
🧬

Biotech and Industrial R&D

Bioreactors, growth chambers and incubators with temperature control critical to reproducibility. Early adopters with high referral potential.

Process T° Multi-point History
🏭

Pharmaceutical, Production and R&D

Production environments, laboratories and stability chambers with GxP requirements for continuous environmental control and per-batch documentation.

GxP Controlled environment Per batch
🎓

Universities and Institutes

Environmental control for research laboratories with reproducibility requirements, and history exportable for inclusion in scientific publications.

Reproducibility Exportable up to 5 years
🐾

Veterinary and Animal Analysis Labs

Growth of the premium pet market and intensive animal production, increasing regulation, a process similar to the human laboratory setting with traceability requirements.

Regulation T° + Humidity Report

Continuous monitoring.
Metrological traceability.

Hardware with ISO 9001 manufacturing, calibratable and with a certificate available, connected to a platform that retains up to 5 years of exportable history. From the test to the audit, the data exists and is defensible.

01
🔬
Calibration certificate

Available for any PLX model. Metrological traceability valid for ISO/IEC 17025, GxP and accreditation audits.

02
📅
Up to 5 years of history

Continuous retention, logging every offline period. In an audit, the history of the test period is exportable as PDF or CSV, with the device ID and timestamp of each reading.

03
🔍
Per-device traceability

Each reading carries the device's unique identifier. In an audit report or scientific publication, you know exactly which sensor produced each data point.

04
🔔
Real-time variation alert

Alerts by email, webhook and REST API (SMS as an add-on) the moment the condition leaves the specified range, before the test is compromised. Configurable per chamber and per variable.

05
📄
Audit-ready report

PDF with laboratory data, device ID, time charts and specified ranges. Ready for the auditor, for the Technical Manager and for the editorial committee.

06
⏰
Integrated calibration management

Certificate due-date control with automatic alerts before the deadline, no external spreadsheet, no surprises in an audit.

→ From sensor to accreditation

Deployed in days.
Accreditable from the first data point.

1

Installation

PLX devices installed in chambers, rooms and test points. Plug-and-play, with no integration with local IT.

2

Calibration

A calibration certificate issued for each device. Metrological traceability from first use.

3

Monitoring

Continuous data on the platform. Configurable alerts. History accumulating from day 1.

4

Audit

Report generated in one click. History of the test period exportable. Calibration traceable per serial number.

⬡ PLX Series, Labs & Research

The right product
for every test condition.

The Environmental family for room and chamber control, Thermal Mapping for critical process points, all calibratable and traceable.

PLX-A300 · Environmental Lux
A300
T° + Humidity + Light, lab rooms and chambers
Temperature Humidity Light
  • Environmental control of the test room with light measurement
  • Ideal for labs with photosensitive control and illuminance (lux) monitoring
  • Up to 5 years of history, exportable for publication and audit
  • Calibration certificate available
  • Per-device-ID traceability on every report
PLX-M200-LT · Low temperature
M200 LT
Ultra-low temperature and deep freeze, –80°C to +10°C
Internal T° Humidity PT100 LT –80/+10°C
  • For ultra-low temperature chambers and biobank ultra-freezers
  • Monitoring of biological samples in deep freeze
  • Alert before thawing, protection of the biorepository
  • Calibration certificate, traceability at low T°
  • Up to 5 years of history, for long-custody samples
◉ Native IoT platform

The data exists.
So does the traceability.

Every reading recorded with a unique device identifier, timestamp and value, turning monitoring into traceable records that support audits for ISO/IEC 17025, GxP and peer review.

📄

Report with device ID

PDF with sensor ID, laboratory data, time charts and specified ranges. Each reading traceable to its origin.

📅

Up to 5 years of history

Continuous retention, logging every offline period. The history of any test period is exportable at any time, even years later.

⏰

Integrated calibration management

Certificate due-date control with automatic alerts. Never be caught off guard in an accreditation audit.

🔔

Alert before variation compromises

Notification by email, webhook and REST API (SMS as an add-on) when the parameter leaves the range, before the test is invalidated. Corrective action with data, not with guesswork.

⏱

Offtime logged

Every period the device is offline is documented. In an audit, you prove monitoring continuity, with no unexplained gaps.

🔐

Secure infrastructure

AWS on a private network, HTTPS + TLS 1.3, encrypted database and 2FA. Research data protected with the same security required for clinical data.

Note: legal or compliance interpretation and classification are the responsibility of a qualified professional; PLEXOR data supports the analysis.

$ The cost of non-traceable data

Losing accreditation
costs more than years of monitoring.

❌ Without traceability

  • 🏛️Suspension or non-renewal of accreditation, direct impact on operations and on analysis contracts
  • 🧬Tests challenged in an audit, retroactive invalidation of results produced without an environmental record
  • 📚Paper rejected for lack of environmental reproducibility data, loss of the publication cycle
  • 💉Batch invalidated by undocumented environmental variation, cost of materials, time and rework
  • ⚖️Liability for a test result with no documented defense

✓ With PLEXOR

  • 📄 Up to 5 years of exportable history, accreditation audit covered from the start
  • 🔬Calibration certificate, metrological traceability valid for ISO/IEC 17025 and GxP
  • 🔔Alert before variation compromises, corrective action with data, not with guesswork
  • 📅Test history exportable, reproducibility data for publication
  • 💡 Clear ROI, the cost of monitoring vs. the cost of a lost accreditation audit
🔬 Where PLEXOR operates

From the test to the publication.
From the process to accreditation.

Clinical analysis laboratories Testing and calibration labs ISO/IEC 17025 accredited labs Pharmaceutical industry, R&D Pharmaceutical industry, production Biotech startups and scale-ups Research institutes Universities and public research bodies Veterinary labs Biorepositories and biobanks CROs, Contract Research Organizations Cosmetics, R&D and stability
Frequently asked questions

Frequently asked
questions.

Does the platform data work as evidence for an accreditation audit?

Yes. The PLEXOR platform generates PDF and CSV reports with device identification, timestamp and historical series, ready for audit. Up to 5 years of history (with the extended-retention add-on) covers the periods required by most accreditation protocols.

How often do the sensors need to be calibrated?

Calibration frequency depends on the application and the regulatory requirements of each laboratory. The PLEXOR platform includes calibration management with due-date control and automatic alerts, helping prevent equipment from operating beyond its calibration interval.

Can a single system cover cold rooms and incubators at the same time?

Yes. All PLEXOR sensors run on the same platform, regardless of the model or the temperature range monitored. You can view cold rooms, incubators and laboratory environments in a single centralized dashboard.

PLEXOR platform

Calibration under control.

Every device with its latest reading, firmware and maintenance status, including the control of calibration and its due dates that accreditation requires.

See the platform →
plexor.clustertec.com.br
PLEXOR platform device cockpit with maintenance and calibration status
→ Next step

Traceability that
holds up in any audit.

Talk to a PLEXOR specialist. In 20 minutes you will see the device producing traceable data, the history being accumulated and the report ready, live.