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ClogSoft®

VERSION 7.0  |  EMS + BMS

Advanced Environmental Monitoring System for Pharmaceutical Manufacturing — Built for Regulatory Compliance and Operational Precision

🌡️Temperature 22.4°C
💧Humidity 58.2%
📊Diff. Pressure 12.0 Pa
🛡️ USFDA 21 CFR Part 11 🛡️ EU GMP Annex 11 🛡️ GAMP-5 Validated 🛡️ ISO 9001:2015
99.97% Uptime — Last 12 Months

01 — The Compliance Challenge

What Every Pharma Facility Faces

Environmental monitoring failures are among the leading causes of regulatory action. Temperature excursions, humidity deviations, and differential pressure failures put product quality — and patient safety — at risk.

📋
483

FDA Observations on Data Integrity

Data integrity violations are consistently among the top causes of FDA Form 483 observations. Manual systems cannot withstand modern regulatory inspection.

🌡️
24/7

Continuous Monitoring Required

Cold rooms, HVAC, stability chambers, and warehouses demand uninterrupted monitoring of temperature, humidity, and differential pressure with zero data gaps.

✍️
100%

Full Electronic Traceability

Every data entry, threshold change, and report must carry a timestamped electronic signature — permanently recorded and tamper-proof.

02 — System Architecture

ClogSoft® 7.0 End-to-End Architecture

From precision field sensors measuring temperature, humidity, and differential pressure — to secure server — to every authorised device

🌡️TEMPERATURE22.4°C 💧HUMIDITY58.2% 📊DIFF PRESS12.0 Pa SD Card — No Data Loss CALIBRATED SENSORSWiFi / RS-485 · 24VDC / 230VAC ☁️⚙️SECURESERVERMySQL Database ENCRYPTED STORAGEBackup + Recovery · Data Integrity 🖥️10" HMI DISPLAYSound Alert &Acknowledgment 💻ClogSoft® PORTALAny Device · Any BrowserAuthorised Login 📱SMS / TELEGRAMLive Deviation AlertsEmail Notifications CLIENT DEVICESMonitor · Analyse · Print

03 — The Product

TEMP22.4°C RH58.2%RH
DP · WiFi · SD Backup

IoT Hardware Meets Compliance Software

The CBROZ CIPL-TRH-24 sensor system pairs with ClogSoft® to deliver continuous, validated monitoring of temperature, humidity, and differential pressure. Data transmits wirelessly over WiFi to a secure server, with an onboard SD card providing local backup.

Every reading is timestamped by a real-time clock, stored in an encrypted MySQL database, and accessible through the ClogSoft® portal from any authorised device.

WiFi & RS-485SD Card Backup3.5" TFT DisplayUltra-Low PowerSS304 / SS316Calibrated SensorsDiff. Pressure Ready

04 — Platform Capabilities

ClogSoft® 7.0 — Core Capabilities

Engineered to satisfy every requirement of FDA 21 CFR Part 11 and EU GMP Annex 11 from day one

🔐

User Access Control

Role-based access with automatic session timeout and lockout after failed attempts.

✍️

Electronic Signatures

Digital signatures provide full legal validity per 21 CFR Part 11.

📜

Comprehensive Audit Trails

Every action is permanently recorded with precise timestamps — tamper-proof.

🔒

Data Encryption & Security

All data encrypted in transit and at rest. MySQL database ensures integrity.

🚨

Real-Time Deviation Alerts

SMS, Telegram, and Email notifications the moment any parameter deviates.

📊

Tailored Report Generation

Customisable reports in non-editable PDF format — print-ready for audits.

☁️

Secure Storage & Retrieval

Complete backup and recovery. Historical data accessible for analysis.

🔑

Stringent Password Policy

Min 8 characters with uppercase, special, and numeric — admin-controlled expiry.

🛠️

Administrator Functions

Full authority over user management, audit trail analysis, and system configuration.

05 — Monitoring Dashboard

Live Environmental Monitoring

Real-time temperature, humidity, and differential pressure data across all facility zones

ClogSoft® 7.0 (EMS + BMS)   All Systems Within Specified Limits Harman Finochem Ltd, Shendra
Cold Room — CR-01
4.2°C
62%
15 Pa
NORMAL
Stability Chamber — SC-04
25.1°C
60%
22 Pa
NORMAL
FG Store — WHD-006
22.8°C
55%
18 Pa
NORMAL

⚠ DEVIATION ALERTS

09:14 — CR-01 Temp exceeded limit by 0.3°C. Acknowledged.
07:52 — SC-04 Door open. Acknowledged by QA.
Yesterday — Maintenance window completed. All clear.

📝 AUDIT TRAIL — RECENT

11:02:14   user.qa@pharma   PDF Exported
10:48:37   admin@pharma   Threshold Updated
09:30:01   user.qa@pharma   Login · Session Start

06 — Regulatory Compliance

🇺🇸

USFDA 21 CFR Part 11

Full compliance with FDA regulation on electronic records and signatures. Audit trails, electronic sign-off, and non-editable records included.

🇪🇺

EU GMP Annex 11

Meets European GMP guidelines for computerised systems. Suitable for facilities supplying regulated European markets.

📐

GAMP-5 Framework

Designed and validated per GAMP-5 for computerised system validation — structured, risk-based lifecycle management.

Built for Audit Day

ClogSoft® 7.0 was designed with regulatory inspectors in mind. Every data point is fully traceable. Every user action carries a timestamp. Every report is non-editable and print-ready.

CBROZ provides comprehensive qualification support covering all three stages of the validation lifecycle.

IQ
Installation Qualification
OQ
Operational Qualification
PQ
Performance Qualification
Documentation Management: ClogSoft® 7.0 organises and stores all electronic records efficiently, ensuring your facility maintains a complete, inspection-ready compliance archive at all times.

07 — Hardware Configurations

Select the Right Configuration

Two mounting options with multiple connectivity and sensor combinations — all in SS304 or SS316 enclosures

🟩 Square Type Mounting

Dimensions215 × 43 × 215 mm
Display3.5" TFT LCD Portrait
Supply Options24VDC or 230VAC
ConnectivityWiFi or RS-485
Sensors AvailableTRH External, DP Internal
Enclosure MaterialSS304 / SS316

🟦 Round Retrofit Mounting

DimensionsØ127 mm × 30 mm
Display2.4" or 3.5" TFT LCD Portrait
Supply Options24VDC
ConnectivityWiFi or RS-485
Sensors AvailableTRH, DP Internal, Temp Only
Enclosure MaterialSS304 / SS316
PART NO.MOUNTINGSUPPLYCONNECT.TRHDPSENSOR TYPE
S-TRH-W-24PESquare24VDCWiFiYESNOExternal Probe
S-TRHDP-W-24PESquare24VDCWiFiYESYESTRH Ext, DP Internal
S-TRH-W-230PESquare230VACWiFiYESNOExternal Probe
S-TRH-R-24PESquare24VDCRS-485YESNOExternal Probe
R-TRH-W-24PERound Retrofit24VDCWiFiYESNOExternal Probe
R-TRHDP-W-24PERound Retrofit24VDCWiFiYESYESTRH Ext, DP Internal
R-DP-W-24LIRound Retrofit24VDCWiFiNOYESDP Internal
R-T-W-24LERound Retrofit24VDCWiFiTEMP ONLYNOExternal Probe

08 — Trusted Partners

Deployed. Validated. Trusted.

Trusted Partners – Cipla, Harman Finochem, Glenmark, Enzene Biosciences, Datar Cancer Genetics, Duracool HVAC

09 — What Our Partners Say

Trusted by Industry Leaders

Real feedback from quality and engineering teams at top pharmaceutical companies

“ClogSoft® 7.0 transformed our stability chamber monitoring. The automated PDF reports saved us 10+ hours per audit preparation. Truly a 21 CFR Part 11‑ready system.”
Amit R.
QA Manager, Harman Finochem
“The retrofit mounting option allowed us to upgrade our legacy sensors without any facility downtime. The CBROZ team handled IQ/OQ flawlessly.”
Dr. Priya S.
Plant Head, Cipla
“We installed 12 nodes across our Chhatrapati Sambhajinagar (formerly Aurangabad) plant. The live dashboard and Telegram alerts give our QA team complete peace of mind.”
Vikram M.
Engineering Lead, Glenmark
“ClogSoft® helped us pass an FDA inspection with zero observations on environmental monitoring. The audit trail feature is outstanding.”
Sneha K.
Compliance Director, Enzene Biosciences
“ClogSoft® 7.0 transformed our stability chamber monitoring. The automated PDF reports saved us 10+ hours per audit preparation. Truly a 21 CFR Part 11‑ready system.”
Amit R.
QA Manager, Harman Finochem
“The retrofit mounting option allowed us to upgrade our legacy sensors without any facility downtime. The CBROZ team handled IQ/OQ flawlessly.”
Dr. Priya S.
Plant Head, Cipla
“We installed 12 nodes across our Aurangabad plant. The live dashboard and Telegram alerts give our QA team complete peace of mind.”
Vikram M.
Engineering Lead, Glenmark
“ClogSoft® helped us pass an FDA inspection with zero observations on environmental monitoring. The audit trail feature is outstanding.”
Sneha K.
Compliance Director, Enzene Biosciences
📚 Explore Case Studies →

Ready to Monitor,
Comply, and Scale?

Contact CBROZ to arrange a facility demonstration. Our engineering team will guide you through deployment, validation, and qualification — from the first day of engagement.

Emailinfo@cbroz.com
Websitewww.cbroz.com
Phone+91 9970 979 603
AddressChhatrapati Sambhajinagar (formerly Aurangabad), Maharashtra

11 — Frequently Asked Questions

Everything you need to know

What is the difference between EMS and BMS? +
Environmental Monitoring System (EMS) specifically tracks temperature, humidity, and differential pressure in critical pharma areas. Building Management System (BMS) manages overall facility HVAC and utilities. ClogSoft® 7.0 integrates both into a single validated platform.
How does ClogSoft® ensure 21 CFR Part 11 compliance? +
ClogSoft® provides full electronic signatures, immutable audit trails, role‑based access, and non‑editable PDF reports, satisfying all FDA electronic record requirements.
Can ClogSoft® be integrated with existing sensors? +
Yes. ClogSoft® supports standard 4‑20mA, RS‑485, and WiFi sensors. Our retrofit mounting option allows you to upgrade legacy monitoring without replacing existing probes.
What kind of support does CBROZ provide during audits? +
We offer comprehensive IQ/OQ/PQ documentation, onsite validation support, and training. Our systems are designed to make regulatory inspections smooth and stress‑free.
Ready to see ClogSoft® in action?
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