Q1. Why choose a paper-based system (EZQS) instead of eQMS software?
A: Software is just a tool; the logic is what matters. Many companies fail audits because they digitize bad processes. EZQS builds a perfect "Quality Architecture" on paper first. This is cost-effective, requires no computer validation (CSV), and is the fastest way to become audit-ready.
Q2. How do I decide between the Lite and Full packages?
A: If you are a bio-startup or a support vendor (e.g., gas, laundry) needing a basic compliance baseline, choose Lite. If you are a pharmaceutical manufacturer or exporter facing strict FDA/EMA inspections, you need the detailed work instructions and forms included in the Full package.
Q3. Can we customize the system for our specific facility?
A: Yes. EZQS is designed as a "Standard Model," but every facility is unique. Our Consulting Service provides Gap Analysis and customization to align the SOPs perfectly with your specific equipment, layout, and organizational structure.
Q4. Does EZQS guarantee FDA compliance?
A: EZQS is engineered strictly based on the FDA 6 System Inspection Model. It covers all 59 required elements. While compliance depends on your execution, EZQS provides the most robust and logical foundation to defend your quality system during an audit.
Q5. How long does the implementation take?
A: Speed is our strength. Unlike eQMS implementation which can take 6-12 months, EZQS can be deployed in as little as 2-4 weeks for the Lite package. We provide the master templates immediately, allowing your team to focus on training and execution rather than writing documents from scratch.
Q6. Is the system available in multiple languages?
A: Yes. We offer EZQS in both English (for global compliance/exports) and Korean (for domestic operations). We also provide bilingual versions to facilitate seamless communication between local staff and foreign auditors.
Q7. Do you provide updates for regulatory changes?
A: Absolutely. Regulations (FDA, EMA, PIC/S) evolve, and so should your system. We provide periodic update notifications and revised template options for our clients to ensure your Quality Manual and Policies remain current with the latest global standards.