Configuration Baselines
Capture approved configuration baselines that freeze the exact state of a product, system, or document set at key lifecycle milestones. Establish a controlled reference point so every subsequent change can be measured, justified, and traced back to a known-good configuration.
Key Capabilities
What you get with the Configuration Baselines module.
See Change Control in action
Watch how MoniDoseQMS handles change control workflows end-to-end.
Core quality
Document control and quality events
Controlled documents with approvals, plus the quality events that keep a QMS alive: changes, deviations, non-conformances and CAPA.
Product
Design and development
Design controls from user needs to validation, with configuration items, baselines, releases and label masters.
How It Connects
Configuration Baselines doesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.
Ready to see Configuration Baselines in action?
Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Configuration Baselines works within your specific compliance context.
More in Change Control
Explore other modules in the Change Control category.
Change Control
Manage every change to your products, processes, and quality system through a structured, risk-assessed workflow. Ensure all changes are properly evaluated, approved, and implemented with full traceability to affected documents, training, and regulatory submissions.
Configuration Items
Track and manage the configuration of your products, systems, and critical components throughout their lifecycle. Maintain a clear record of what changed, when it changed, and why, ensuring full traceability for regulatory compliance.
Configuration Releases
Manage the controlled release of product and system configurations from a defined baseline into production, market, or service. Ensure every release is reviewed, approved, and documented so only authorized configurations are ever deployed or distributed.
PRRC Commitments
Track the obligations of your Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR Article 15. Document every regulatory commitment the PRRC oversees so conformity, vigilance, and post-market obligations are demonstrably met and never missed.
Post-Registration Review
Evaluate changes to registered products to determine if regulatory submissions or notifications are required. Streamline your post-registration review process to ensure changes are assessed against global regulatory requirements before implementation.