Case Study

QMS platform

ISO-aligned QMS platform with audit-ready traceability. We built a QMS foundation to manage document control, audits, findings, CAPA, evidence, and management review with governance, accountability, and consistent closure discipline.

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Governance and audit trails Role-based workflows Evidence-first closure

Project snapshot

Controlled documents, audit execution, CAPA discipline, and management review built into one system of record.

Document control

Versioning, approvals, controlled access, and audit trails designed for accountability and traceability.

Audit execution

Audit plans, schedules, checklists, responses, and findings with structured classification and closure.

CAPA and evidence

Corrective actions tracked with deadlines, ownership, and evidence required to close for consistent governance.

Overview

A modern QMS platform designed to unify quality operations under a single system of record: controlled documents, audits, findings, CAPA, evidence, and management review. The design focuses on clarity, traceability, and disciplined closure without spreadsheet drift.

Document control with versioning, approvals, and controlled access
Audit planning, checklists, findings, and closure workflows
CAPA with classifications, deadlines, and evidence requirements
Management review structure aligned to agenda and outcomes
Reporting foundation for visibility and accountability

Key outcomes

Reduced manual audit administration and spreadsheet drift
Improved closure discipline with evidence required to close
Clear audit trail for approvals, changes, and corrective actions
Faster onboarding of departments and responsible persons
Better visibility into open items, timelines, and risk

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Common challenges

Documents living in shared drives without consistent control
Audit findings tracked across emails and spreadsheets
CAPA closure without evidence or consistent governance
Limited visibility into open items and timelines
Inconsistent classifications and incomplete corrective actions

What we delivered

Structured audit setup with department-based checklists
Finding classifications and mandatory comments where required
Evidence upload requirements for closing findings and CAPA
Role-based workflows aligned to governance expectations
Reporting-ready data model for operational visibility
Management review structure aligned to agenda, analysis, and decisions

Implementation approach

Requirements mapping to quality policy and organizational structure
Workflow design for audits, findings, CAPA, approvals, and evidence
Incremental rollout by module to avoid operational disruption
Training and governance setup for consistent adoption
Operational reporting definitions so dashboards match decisions

Operational discipline

Clear ownership and due dates
Standardized status transitions and closure criteria
Evidence-first closure to prevent paper compliance
Audit trails for changes, approvals, and exceptions

Security and governance

Access control and traceability are built into the foundation so organizations can operate with accountability and inspection readiness.

Role-based access control and accountability
Audit trails for changes and approvals
Evidence storage aligned to retention expectations
Deployment options aligned to client security requirements

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