'Digital Paper' is Still Waste
Simply scanning PDFs onto a server isn't digitalization—it's creating 'digital paper' that keeps your processes slow, disconnected, and vulnerable to human error.
The Signature Hunt
Engineers wasting days walking around to get physical signatures for a single document.
The Version Trap
Manufacturing using obsolete versions of SOPs because a central binder wasn't updated.
Audit Panic
Scrambling to find training records or CAPA files during an unannounced inspection.
The Leanabl Insight
True eQMS isn't about digital storage; it's about digital flow. We create connectivity between your Design Controls, Risk Management, and Post-Market Surveillance data, turning your QMS into a source of business intelligence.
Seamless Digital Migration & Validation
We architect the entire migration process, partnering with leading eQMS platforms like Greenlight Guru, MasterControl, and Dot Compliance to deliver a fully validated system.
Workflow Architecture
We map your existing paper processes and architect automated digital workflows for CAPA, Document Control, and Training, including setting up permission structures.
Legacy Data Migration
Our team develops a strategy to sanitize, format, and bulk-import your historical DHF and DMR records into the new system, ensuring a clean data transfer.
Computer Software Validation (CSV)
We execute the full validation package (IQ/OQ/PQ protocols) to ensure your eQMS is compliant with FDA 21 CFR Part 11 for electronic records and signatures.
The 'Go-Live' Roadmap
We bridge the gap between your IT, Quality, and Operations teams to ensure a successful launch.
Gap Assessment
We analyze your current processes to define the User Requirement Specifications (URS) for the new system.
Build & Validate
We configure the eQMS platform and execute the full Computer Software Validation (CSV) package.
Training & Launch
We train your team on the new digital SOPs to ensure high adoption and a smooth transition.
Your Complete Validation Package
Fully Configured eQMS
A live, validated environment ready for your team.
Validation Package
A complete IQ/OQ/PQ and VSR report for auditors.
Digital SOPs
Your core quality procedures, updated for the new workflows.
Why We Are Better Than Software Vendors
Process First, Tool Second
We aren't just IT implementers; we are quality system experts. We help you fix broken processes so you don't simply automate bad habits.
KGMP Ready
We configure your system with specific workflows and record types needed to satisfy the unique requirements of Korea GMP (an ISO 13485 derivative).
Audit Defense Training
We don't just hand you the keys. We teach your team how to "drive" the eQMS during an audit, ensuring they can confidently navigate and present records to inspectors.
Quality at the Speed of Software.
Eliminate the friction of paper, binders, and wet-ink signatures. Automate your compliance and accelerate your time to market.
Start My eQMS Transformation