01
Electronic files
Information exists, but relationships are manually maintained.
QMSpace
Connected lifecycle execution with end-to-end traceability
QMSpace is a digital platform that connects medical-product lifecycle activities, requirements, CQAs, risks, objective evidence, quality processes, regulatory submissions, and proven knowledge in one governed product context.
QMSpace: Connected lifecycle execution. Connects lifecycle activities, requirements, risks, CQAs, V&Vs, quality systems, and regulatory submissions.
From files to connected execution
Structure information once. Use it throughout the lifecycle.
02
Structured records
Requirements, CQAs, risks, controls, evidence, ownership, and status become governed data.
03
Connected product model
Teams navigate traceability, dependencies, architecture, and change impact.
04
Controlled outputs
Reports, matrices, approvals, and regulatory content use current source data.
QMSpace in practice
Connected capabilities across the medical-product lifecycle
Explore representative QMSpace capabilities. Each view shows how structured data, relationships, and deliverables remain connected inside one governed product context.
Design Controls
Connect product intent, requirements, design, verification, and validation
Manage design-control data, relationships, and deliverables as connected information rather than isolated documents.
Connected operating model
Connect the quality system to the products and evidence it governs
QMSpace can bring quality-system processes, product-development work, and regulatory and lifecycle information into one connected environment.
Quality SystemDocuments · Training · CAPA · Change · Suppliers · Complaints
QMSpace connected digital backbone
Product DevelopmentNeeds · CQAs · Requirements · Risks · Controls · V&V · Evidence
Regulatory & LifecycleSubmissions · Post-market · Change impact · Reuse
Enterprise fit
Connect what matters without replacing everything
QMSpace can serve as a connected product-knowledge layer across established systems. The appropriate interface is confirmed during solution design.
PLM
ALM
eQMS
MES / ERP
Documents
Regulatory tools
QMSpace connected knowledge layerTraceability · context · reuse · change impact · evidence
Integration may use supported APIs, configured interfaces, or controlled file exchange.
Implementation
Start with a real use case and scale deliberately
QMSpace provides an out-of-the-box configuration for regulated medical products based on industry best practices, then adapts to the organization’s products, processes, systems, and intended use.
Out-of-the-box medical-product foundation
Start from proven industry structure, not a blank generic platform
Preconfigured work-item types, attributes, relationships, lifecycle views, workflows, and reporting structures provide a practical starting point that can be tailored without rebuilding the platform.
1
Start
Select the relevant medical-product foundation and real business use case.
2
Tailor
Adapt records, relationships, workflows, permissions, views, and reports.
3
Launch
Apply QMSpace to a representative product, platform, or workflow.
4
Scale
Train users, govern libraries, streamline reuse, and expand to additional programs.
See QMSpace on a workflow relevant to your organization
A tailored demonstration focuses on the lifecycle activities, relationships, evidence, reviews, and integration questions that matter to your intended use.