Change Requests, CAPAs & NCs
Nonconformance, CAPA, and
Change Control in One System.
Manage investigations, corrective and preventive actions, and controlled changes while keeping related records and documents connected throughout the process.
Separate Processes.
Connected Records.
Nonconformances, CAPAs, and change requests remain distinct records, with related Quality records and documents connected when your process requires them.
Nonconformances
Assess, Investigate, and Resolve Nonconformances.
Capture and assess the nonconformance, investigate what happened, document disposition, and manage the record through resolution.
Investigation Context
Keep related records and documents available throughout the investigation.
CAPA Connection
Create a CAPA when required or connect an existing CAPA.
CAPA
Investigate Root Cause and Define Corrective Action.
Investigate root cause, define corrective and preventive actions, and manage the CAPA through implementation and verification.
Root Cause Investigation
Document investigation findings and the identified root cause.
Corrective & Preventive Actions
Define the actions required in a controlled action plan.
Change Control
Control Changes
Through Review & Release.
Define the scope and impact of a change, prepare revisions to affected documents, and complete the required review and release.
Request & Scope
Define the reason for change, potential impact, and affected documents.
Draft Changes
Prepare proposed changes to the documents included in the request.
Review & Approval
Review proposed changes and complete required sign-off and approval.
Execution & Release
Carry out the approved change and complete the Document Control release.
Keep Related Quality Records Connected and Traceable.
Maintain the relationships between complaints, nonconformances, CAPAs, change requests, and affected documents so teams can follow the records and actions associated with a Quality process.
Questions?
Still have questions? We’ve got you covered.
If it’s not covered here, reach out or book a demo to see Cytodyme in action.
Can Cytodyme match our existing NC, CAPA, and Change Control workflows?
Yes. Configure the forms, required information, responsibilities, and review steps around your procedures. Nonconformance, CAPA, and change control each retain their own workflow, so your team can manage them according to their different requirements.
Does every nonconformance need to create a CAPA?
No. Your team assesses the nonconformance and determines the appropriate disposition. When a CAPA is needed, you can create or link the CAPA and preserve its relationship to the originating record.
Can related complaints, NCs, CAPAs, and change requests stay connected?
Yes. Link related records so your team can follow an issue through its investigation and resulting actions. For example, a CAPA can reference the nonconformance it originated from, while a change request identifies the documents affected by the change.
Can multiple documents be included in the same change request?
Yes. A change request can include multiple affected documents. Your team can prepare and review each revision within that request, keeping the documents together through the required approval and release process.
What happens to records already in progress when a workflow changes?
Changes to a workflow go through review and approval. Records already in progress continue under the version they started with, while new records use the updated configuration once it becomes effective.