Standardize Change Control with structured workflows that ensure compliance, reduce delays, and provide full traceability.
Standardize Change Control with structured workflows that ensure compliance, reduce delays, and provide full traceability.
In regulated industries, uncontrolled change is a top compliance risk. Whether modifying an SOP, updating a validated process, or introducing a new material, changes must be documented, assessed, and approved before execution.
Quality Forward’s eQMS delivers an end-to-end Change Control solution that ensures visibility, traceability, and compliance across every stage. Built to align with FDA, EMA, ISO, and ICH Q10 standards, it helps life sciences teams enforce control while accelerating decision-making.
Centralize change requests across documents, equipment, suppliers, and systems.
Evaluate risks, dependencies, and regulatory impact before approval.
Route changes through automated, role-based workflows
Perform structured evaluations tied to affected documents, systems, or processes
Initiate and track change controls in a single, centralized platform
Use configurable workflows for routing based on change type, site, or severity
Track supporting evidence, review cycles, and approval history in one place
Monitor change status, overdue tasks, and cycle time across teams or sites
Meet FDA 21 CFR Part 820/211, ISO 13485, EU Annex 11, and ICH Q10 requirements
Adapt workflows, approval chains, and forms—without custom code
Purpose-built for startups, scale-ups, and enterprise life sciences companies
Built by experts who know FDA, EMA, GxP, and ISO expectations inside and out
Identify high-risk changes, process delays, and systemic bottlenecks
Enterprise-grade infrastructure for speed, security, and stability
Meet global standards with validation-ready workflows and secure audit trails
Submit structured forms with required details, justification, and attachments
Evaluate affected systems, SOPs, batches, or suppliers using built-in tools
Automatically assign reviewers and approvers based on risk and function
Execute changes, trigger training or documentation updates, and confirm completion
Monitor change cycle times, overdue steps, and approval bottlenecks
