Changes

Intelligent change control for pharmaceutical manufacturing. Every impact assessed by AI. Every approval routed automatically. Every change classified by regulatory requirement.

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Built for Controlled Change Execution

AI maps the ripple effects of every change across documents, training, equipment, and regulatory filings, before a single approval is requested.

Leucine Changes connects to every part of the quality system. When a high risk score triggers a change request from the Risks app, or a regulatory update from FDA triggers a change, the Changes app assesses impact across documents, training, batch records, and equipment. Approval workflows route to the right stakeholders. And when the change is approved, downstream updates flow automatically, SOPs are revised in Documents, batch records are updated in MES, and affected personnel are retrained through Learning.

AI Impact Assessment

AI maps the full ripple effect of every proposed change, across documents, training records, equipment qualifications, batch records, and regulatory filings, before the change is submitted for approval.

Cross-System Impact Mapping.

AI traces the proposed change across every connected system, identifying affected SOPs, training assignments, batch records, equipment qualifications, and regulatory submissions.

Document Impact Analysis.

Every SOP, protocol, and specification affected by the change is identified automatically, with links to the specific sections that require revision.

Training Requirement Detection.

Personnel whose roles are affected by the change are identified, and training requirements are calculated based on the scope and nature of the modification.

Regulatory Filing Assessment.

AI determines whether the change triggers regulatory notification requirements, variation filings, annual report entries, or pre-approval supplements.

Auto-Generated Implementation Plans

Implementation plans are generated automatically from the change scope, with tasks, owners, timelines, and dependencies mapped out before the first approval is granted.

Task Generation.

AI breaks the change into implementation tasks based on its scope, document revisions, equipment requalification, training updates, and validation activities.

Timeline Planning.

Tasks are sequenced with realistic timelines based on historical implementation data, accounting for dependencies, resource availability, and regulatory hold points.

Resource Allocation.

AI suggests task owners based on departmental responsibility, expertise, and current workload, ensuring changes are assigned to the right people.

Progress Tracking.

Real-time dashboards show implementation progress by task, owner, and milestone, with automatic escalation when deadlines are at risk.

Smart Approval Routing

Changes are routed to the right approvers based on change type, impact area, regulatory classification, and organisational responsibility, with parallel reviews for faster cycle times.

Auto-Assigned Approvers.

Approval chains are determined automatically based on change type, affected departments, and regulatory impact, no manual routing required.

Multi-Level Workflows.

Configurable multi-level approval workflows with parallel and sequential stages, engineering review, QA review, regulatory review, and management approval.

SLA Tracking.

Review deadlines are enforced with automated reminders and escalation rules, ensuring changes don't stall in approval queues.

Complete Audit Trail.

Every approval decision, comment, and routing action is recorded with timestamps, user identity, and electronic signatures.

Regulatory Classification

Changes are automatically classified according to FDA, EMA, and ICH frameworks, determining whether prior approval, notification, or annual reporting is required.

FDA Classification.

Changes are classified as major, moderate, or minor per FDA guidance, with automatic determination of supplement type (PAS, CBE-30, CBE-0, or annual report).

EMA Variation Typing.

AI determines the EMA variation type, Type IA, IB, or Type II, based on the nature and scope of the change.

Notification Requirements.

Regulatory notification deadlines are calculated automatically and tracked to ensure timely submission to all applicable authorities.

Pre/Post-Approval Routing.

Changes requiring pre-approval are held at a regulatory gate, while post-approval changes proceed with appropriate documentation for annual reporting.