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Change Management

Manage change at every level across your enterprise

Embrace a Proactive Approach to Change Management

Manage change with control and traceability across all quality processes.

Reduce Risk

Uncontrolled changes can create serious compliance and quality risks. Even minor updates to processes, materials, or documents can cause deviations or recalls. Dot Compliance provides structured change management with evaluation, review, and approval built in. Each change is fully traceable and linked to related records like CAPAs and deviations, ensuring all impacts are assessed. The system supports FDA 21 CFR Parts 210, 211, and 820, ISO 13485, and GxP requirements to maintain product quality and regulatory compliance.

Accelerate Time-to-Market

Controlled change management accelerates progress by standardizing reviews and approvals. Automated routing and reminders replace manual steps, ensuring every change moves efficiently through the process. Dot Compliance connects quality, regulatory, and operations teams in one system so everyone works with the same information. This alignment eliminates duplicate work, improves visibility, and helps teams act quickly—shortening development timelines while maintaining full regulatory control.

Boost Efficiency

Efficient change management saves time and boosts productivity by replacing spreadsheets and paper forms with a centralized digital process. Automated workflows route tasks, ensure accountability, and keep changes on track. Dot Compliance gives managers visibility into all open and completed changes, helping identify bottlenecks and allocate resources effectively. Linked records between documents, products, and equipment make every change traceable, reducing errors and supporting continuous improvement.

Dot Compliance change management provides a standardized process with workflow flexibility, allowing life sciences manufacturers to manage all types of changes from one centralized platform. The ability to manage and control changes is critical for life sciences organizations to ensure quality, meet business challenges, and maintain GxP compliance.

Why Dot Compliance Change Management

Change influences quality

Dot Compliance change management monitors all types of changes. These changes can influence reliability or product quality and impact relevant requirements.

Facilitate changes and track updates

Following GMP/ISO standards and requirements, all changes must be documented to prove that the change was evaluated and the subsequently defined measures were implemented as predetermined. With a cloud-based eQMS, companies have better data control and drive data quality significantly, allowing for collaboration across all departments.

Easily manage change updates, including documents, products, and equipment

Dot Compliance’s change management solution allows organizations to manage change updates from anywhere at any time.

Traceability across all changes

With Dot Compliance, you can trace the change and understand its impact across the eQMS.

The eQMS that keeps you one step ahead

Dot Compliance is the industry’s first AI-powered eQMS, built to get you up and running fast and to give you the insights to drive quality efficiently.

Smart solutions for life sciences companies at every stage

Meet the eQMS that evolves with you, from setting a foundation with core processes to the industry’s most sophisticated AI quality and compliance intelligence.