Q-Nest eQMS Application Implementation Roadmap

Step 1: Gap Analysis & Scoping

We understand your unique Quality Landscape.

What we do: Audit your current SOPs, paper forms, Existing digital set-up and workflows.
The Goal: Define a "Configuration Blueprint" that fits your site’s specific needs without over-complicating the system.

Step 2: System Configuration & Design

We tailor the eQMS modules (CAPA, Deviation, Change Control, Vendor Management) to mirror your approved SOPs.

What we do: Set up user roles, approval hierarchies, and automated notification triggers.
The Goal: A system that feels familiar to your team but operates with digital speed.

Step 3: Computer Software Validation (CSV)

This is the most critical step for GxP compliance. We don't just "install"; we validate.

What we do: Execute the V-Model approach—delivering the Validation Plan, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
The Goal: A "Validation Summary Report" that is ready to be handed to any FDA or MHRA inspector.

Step 4: User Acceptance Testing (UAT) & Training

We ensure your "Power Users" and "End Users" are confident before Go-Live.

What we do: Hands-on training sessions and UAT scripts to ensure the system performs exactly as intended in a "sandbox" environment.
The Goal: 100% user adoption and zero "human error" friction.

Step 5: Go-Live & Post-Migration Support

We transition your data and "flip the switch" to a digital QMS.

What we do: Hyper-care support during the first 30 days of live use and final legacy data archival.
The Goal: A fully operational, 21 CFR Part 11 compliant system that is audit-ready from Day 1.