VALITRACE
By YHWorks Tech Private Limited

STOP FILLING OUT FORMS. START GETTING ANSWERS.

VALITRACE is the intelligent electronic logbook system built for pharmaceutical, food, and chemical manufacturing — 21 CFR Part 11 compliant, AI-powered, and live in weeks.

See How It Works
60–70%
Reduction in
logging time
4–6 WKS
Go-live
timeline
21 CFR
Part 11
compliant
Audit Trail Status
All Clear
Last verified: 2 minutes ago
Active Log Points
47 / 47
Zero deviations detected
Daily Error Reduction
90%
vs manual logbooks this period
AI Query — Answered in 1.2s
"Show all deviations in Reactor Line 3 this month"
The Challenge

MANUAL LOGS ARE
COSTING YOU

Your operators waste hours daily. Your QA team drowns in paperwork. Your auditors keep finding errors. And with every inspection, the stakes get higher.

01
Compliance & Audit Vulnerabilities
Missing signatures, undated entries, illegible handwriting, and inability to prove data integrity during FDA, EU GMP, FSMA, or ISO audits.
02
Data Integrity & Traceability
Paper logs are susceptible to human error, lost pages, unauthorized alterations — making root cause analysis slow and CAPA closure painful.
03
Operational Inefficiencies
Staff waste 2–3 hours daily on repetitive data entry. Shift handover gaps, missed critical communications, and delayed supervisor response are systemic.
04
No Real-Time Analytics
Insights that should take minutes require days of manual transcription. Temperature excursions and equipment failures go unnoticed until someone physically checks.
05
Storage & Retrieval Nightmares
Regulations mandate retention of 5–30+ years. Physical storage degrades. Finding a specific entry from 3 years ago during an audit takes hours — not seconds.
06
Consequences Are Severe
Pharma faces regulatory shutdowns and product recalls. Food service risks health violations. All industries share the same root frustration: manual logs cannot scale.
The Solution

INTELLIGENT
ELECTRONIC
LOGGING

VALITRACE digitizes and automates log keeping for pharmaceutical, food, and chemical manufacturing — ensuring full regulatory compliance with the intelligence to make your data work for you.

Everyone promises electronic logbooks. We're the only ones who add intelligence.

📱
Web & Tablet Entry
Capture logs from anywhere on the manufacturing floor
📊
Conventional Reports
Standard compliance reports and real-time dashboards
🤖
AI Query Module
Ask questions in plain English, get instant insights
✅
21 CFR Part 11
Full audit trails and electronic signatures built-in
Key Features
01
Configuration
Highly Configurable Log Form Module
Design log forms exactly as your SOPs require — with field types, validations, conditional logic, and approval workflows. No coding. Ready in hours, not months.
02
Alerts
Real-Time OOS Alert System
Automated alerts for out-of-specification events, temperature excursions, and missed entries — delivered instantly to supervisors and QA via dashboard, email, or SMS.
03
Analytics
Predictive Analytics for Preventive Maintenance
VALITRACE detects patterns before they become problems — flagging equipment trending toward failure before a deviation occurs and a batch is lost.
04
Integration
Seamless MES / ERP / LIMS Integration
Open APIs connect VALITRACE to your existing manufacturing systems. Works with your ecosystem — not a locked island. Offline logging included; syncs on reconnect.
05
Mobility
True Mobile-First Design
Web and tablet are equal-class interfaces — not a desktop system with a mobile afterthought. 3 taps to complete most entries. Designed for actual operators on the floor.
Regulatory Framework

COMPLIANCE
BUILT IN,
NOT BOLTED ON

GAMP 5, 21 CFR Part 11, ALCOA+ — built from day one, not retrofitted later. VALITRACE is engineered to exceed regulatory requirements so your team can focus on manufacturing, not documentation.

AUDIT READY.
Every time. Without scrambling.
21 CFR PART 11 EU GMP ANNEX 11 GAMP 5 ALCOA+ ISO 9001 FSMA FSSAI CDSCO MHRA EMA
V
Return on Investment

THE NUMBERS
SPEAK CLEARLY

VALITRACE delivers measurable ROI within 6–12 months through time savings, error elimination, reduced audit preparation burden, and compliance risk avoidance.

60–70%
Reduction in Logging Time
Per operator, per shift
90%
Fewer Data Entry Errors
vs paper-based systems
4–6 WKS
Go-Live Timeline
vs 6–12 months for competitors
1/3
The Cost of Enterprise eLogs
Tailored to your scope & complexity
Implementation

STRUCTURED FOR
YOUR COMPLEXITY

Every implementation is scoped to your operation — the number of SOPs, deployment areas, and SOP complexity all shape the timeline. Simpler rollouts can go live in a matter of weeks; multi-site or SOP-heavy environments are planned more carefully to ensure zero compliance gaps. We handle the heavy lifting: forms configuration, validation documentation, user training, and regulatory paperwork are all included.

01
Phase One
Setup & Configuration
We assess your SOPs, deployment areas, and user roles before configuring VALITRACE to match your exact compliance requirements. The more complex your operation, the more thorough this phase — no shortcuts on compliance.
⏱ Timeline varies · Includes Training
02
Phase Two
Parallel Running
VALITRACE runs alongside your existing system — duration depends on the number of SOPs and areas in scope. Your team gains confidence while validation documentation is finalized and sign-off is completed.
⏱ Scoped to your SOPs · Zero Disruption
03
Phase Three
Full Rollout & Optimization
Complete deployment with continuous support and system optimization. Dedicated success manager. 24/7 technical support. Regular system updates included.
⏱ Ongoing · Dedicated Support
Why VALITRACE

BUILT BY PEOPLE
WHO KNOW
SHOP-FLOOR
REALITY

20+
Years of Enterprise Systems Experience
YHWorks has spent two decades building enterprise systems for healthcare, manufacturing, and regulated industries globally. VALITRACE is the product of that accumulated knowledge.
↗
Deep Regulatory Domain Expertise
FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ — we speak the language of pharma compliance fluently, not as a feature add-on but as a foundational design principle.
⚡
Operator-First, Not Demo-First
Complex eLogs fail because operators resist them. VALITRACE is deliberately simple — 3 taps to complete most entries — while delivering enterprise-grade compliance behind the scenes.

We've spent 20 years building enterprise systems. We understand the gap between software demos and shop-floor reality. VALITRACE is designed for actual operators — simple mobile interface, works offline, minimal training needed — while delivering full regulatory compliance. You're not our experiment. You're benefiting from two decades of learning what actually works in regulated environments.

— YHWorks Tech Private Limited · yhworks.com
India
HQ: Navi Mumbai
Operations: Pune
Global
US · Canada · Europe
& India markets

TRANSFORM YOUR
COMPLIANCE PROCESS

Test VALITRACE in one department with no commitment. See AI-powered reporting in action with your own use cases. 30-day trial with full technical support.

Visit YHWorks.com
🚀
Free Pilot Program
Test VALITRACE in one department with no commitment. Full feature access, real data, your SOPs.
🎯
Live Product Demo
See AI-powered reporting in action with your specific use cases. 1-hour personalized demonstration.
🛡️
Risk-Free Evaluation
30-day trial period with full technical support, validation documentation, and dedicated assistance.

Book a demo

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