Digitize plant quality, batch records, and compliance without paperwork.
EazyCom QMS is purpose-built for pharmaceutical, API, and life-science manufacturing plants. Replace paper binders, unversioned spreadsheets, and manual logbooks with an audit-ready system hosted on your private server or private cloud.
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Pre-configured with sample SOPs, BMR templates & inspection checklists.
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See how plant operators log batch deviations, execute 21 CFR Part 11 electronic signatures, and perform QC checks in seconds.
About the Founder : Mission & Vision
Built to eliminate the complexity and cost of pharmaceutical compliance.
"For years, pharmaceutical and life science manufacturing plants have faced an unfair choice: struggle with error-prone paper binders and unversioned spreadsheets, or pay millions in hidden per-seat licensing fees for complex legacy enterprise systems that take 9 months to deploy."
"I built EazyCom QMS to give manufacturing plants an audit-defensible, intuitive system backed by transparent annual plans. Every single plan includes all 12 modules, unlimited shop-floor read-and-sign access, and automated 21 CFR Part 11 electronic audit trails—deployed and validated in days, not months."
"When you partner with us, you work directly with the engineers who design and support your platform. You get immediate technical answers and dedicated plant onboarding from day one."
Join Our Founding Customer Programme
We are selecting 10 pharmaceutical and life sciences manufacturing facilities to participate in our Founding Partner initiative.
Guaranteed preferential pricing locked in perpetuity for your facility.
Weekly engineering consultations to tailor SOP and batch record formats to your plant.
Your compliance and audit requirements get top priority in our release roadmap.
12 Core Operations Modules
Every module is interconnected. Deviations spawn root-cause investigations, CAPAs trigger SOP document updates, and equipment calibrations feed inspection releases.
Document & SOP Control
Author, review, and approve SOPs, Master Formula Cards, and work instructions with 21 CFR Part 11 electronic signatures and automatic version archiving.
Training & Qualifications
Role-based training matrices, automated comprehension quizzes, and On-the-Job Training (OJT) logs. Blocks untrained operators from critical tasks.
Quality Risk Management (FMEA)
Calculate Risk Priority Numbers (RPN = Severity × Occurrence × Detection) under ICH Q9 to objectively prioritize preventive engineering controls.
Electronic Batch Records (eBR)
Real-time manufacturing execution tracking, line-clearance checklists, equipment linking, and raw material lot consumption reconciliation.
CAPA Management
Formulate corrective and preventive action plans with 30/60/90-day effectiveness checks to verify that root causes do not recur.
Deviations & Root-Cause (8D)
Log unplanned deviations, OOS lab findings, and incidents. Guided 8D stepper and interactive 5-Why root-cause trees ensure thorough investigations.
Change Control (ECO)
Formal Engineering Change Orders for process parameters, batch equipment, raw materials, or packaging with cross-departmental impact voting.
Quarantine Holds & MRB
Place suspect lots or rejected raw materials under quarantine hold. Warehouse bay tracking with Material Review Board quorum voting for final disposition.
Audits & Checklists
Schedule internal, supplier, and regulatory audits. Execute interactive tablet inspection checklists on the plant floor and log findings instantly.
QC Testing & Inspections
Incoming (IQC), In-Process (IPQC), and Finished Goods (OQC) sampling with AQL defect limits and digital Certificate of Analysis (CoA) release.
Machine Calibration & PM
Track every production machine, sensor, and analytical tool. Enforce Preventive Maintenance (PM) intervals and store calibration certificates.
Approved Suppliers & Dock Intake
Maintain the Approved Supplier List (ASL). Streamline loading-dock raw material intake, packaging checks, quarantine tagging, and vendor returns.
Fair, Predictable Plans with Zero Hidden Fees
All plans include the full 12 core modules, 21 CFR Part 11 audit trails, and unlimited shop-floor read/sign users.
How Deployment Works
Formulation & API
For small plants or single lines transitioning off paper.
Audit-Ready Plant
For mid-sized plants preparing for WHO-GMP, US FDA, or EU audits.
Multi-Block Sites
For multi-building or multi-line sites with high batch throughput.
Full Plant License
Full plant site license with zero user seat restrictions across all departments.
Download the 21 CFR Part 11 Plant Audit Readiness Checklist
A practical, 18-point checklist covering electronic signatures, audit trails, password security, and computerized system validation to ensure your facility passes its next regulatory audit.
Speak Directly with Our Engineering Team
Schedule a 30-minute private walkthrough. We'll show you how to configure your specific products, review your audit timeline, and prepare your validation documentation.
Book a 30-Minute Plant Walkthrough
Pick a date or ask any technical deployment question. We respond within 2 to 4 hours.