“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry.”
Change Management
Manage change at every level across your enterprise
Join the Industry’s Leading Life Sciences Professionals Who Trust Dot Compliance
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 ready-to-deploy QMS software that delivers speed and smarts
Used by life sciences organizations around the world, Dot Compliance empowers teams to manage quality with confidence, maintain continuous compliance, and keep every process inspection ready.
FAQs
Does the system enable a risk-based approach to change assessment?
Yes, the platform includes a built-in assessment tool that allows users to evaluate and capture the potential impacts and risks of a change before proceeding. This ensures that the level of scrutiny, resource allocation, and approval requirements are proportional to the risk the change poses to product quality or regulatory compliance.
How are change action items tracked and managed?
Action items are managed as discrete, trackable tasks that are assigned to specific owners with defined due dates. The system provides real-time visibility into the status of these tasks via dashboards and reporting, while allowing teams to assign predecessors and successors to enforce a specific order of completion for complex change implementations.
Does the system allow for different change types?
Yes, the platform is designed to be adaptable, allowing teams to specify and define their own distinct change types based on their unique operational needs. This granular categorization enables robust reporting, providing the data necessary for trend analysis and regulatory oversight as required.
How does change management link into other areas of the QMS for impact to areas like documentation, suppliers or other quality events?
The system is built on a unified platform that creates a connected ecosystem across all quality processes. When a change is initiated, the integrated impact assessment allows you to link the change record directly to related documents, supplier profiles, or open quality events like CAPAs and deviations. This cross-functional visibility ensures that a change in one area reflects and is traceable to actions in others, maintaining a holistic and compliant state across the entire quality management system.
Global compliance, baked in
Quality & Compliance Standards
- ISO/IEC 42001 (AI Management Systems)
- ISO 9001 (Quality Management Systems)
- ISO/IEC 27001 (Information Security Management Systems)
- GAMP 5 (Good Automated Manufacturing Practice for GxP Systems)
- ISO/IEC 27017 (Cloud Security)
Medical Device
- 21 CFR Part 820
- ISO 13485
- ISO 14971
Pharma & Biotech
- 21 CFR Part 210
- 21 CFR Part 211
- cGMP, cGDP, GCP