QFacts

Control every change, reduce every risk

From initial request to final closure, QFacts Change Control gives your team structured workflows, impact assessments, and full traceability for every process change.

Key capabilities

Everything you need to manage change in a regulated environment.

Impact assessment workflows
Evaluate the impact of every proposed change across quality, regulatory, safety, and operational dimensions before approval.
Multi-level approval routing
Configure approval chains by change type and risk level. Route changes to the right stakeholders automatically.
Implementation tracking
Monitor change implementation with task assignments, milestone tracking, and real-time progress dashboards.
Regulatory notification management
Automatically flag changes that require regulatory notification and track submission status across agencies.
Complete change history
Maintain a full audit trail of every change request, assessment, approval, and implementation step with electronic signatures.

Six-step change lifecycle

A structured process that keeps changes on track from request to closure.

1

Request

Submit a change request with justification, scope, and initial risk classification.

2

Impact Assessment

Evaluate quality, regulatory, safety, and operational impact with structured assessment forms.

3

Approval

Route through configured approval chains based on change type and risk level.

4

Implementation

Execute the change with task assignments, training updates, and document revisions.

5

Verification

Confirm the change was implemented correctly and produces the expected outcome.

6

Closure

Close the change record with effectiveness data and lessons learned.

Real-world use cases

See how teams rely on QFacts Change Control every day.

Engineering Lead

See how Engineering Lead uses Change Control to propose a manufacturing process change with full impact documentation and route it to the right approvers automatically.

Quality Director

See how Quality Director uses Change Control to evaluate cross-functional impact of proposed changes, approve or request additional information, and track implementation progress.