Quality events
Deviations and complaints with attributable ownership, lifecycle rules, linked evidence and follow-up.
Design partner
Kelavon Life Sciences · Quality
Start with one quality workflow. Keep its evidence connected.
Kelavon Quality is the recommended first enterprise engagement inside Life Sciences. It begins with a bounded operational workflow and the records, roles, decisions and evidence needed to support it—not a promise to replace an entire QMS at once.
Initial workflow scope
Quality operations with visible responsibility and history.
CAPA and effectiveness
Actions remain connected to the originating event, due dates, evidence and effectiveness decision.
Change control
Assess impact, approvals, implementation evidence and resulting document or training obligations.
Audits and findings
Plan audits, retain findings and connect responses, actions and closure evidence.
Controlled documents and training
Keep revisions, approvals, effective status and training relationships visible to the workflow.
Schedules and evidence
Track recurring obligations without separating the schedule from proof of completion.
Included in fit and pilot scope
- Core organization, product, person and reference records
- One agreed quality-event and follow-up workflow
- Roles, lifecycle rules, evidence links and audit history
- Deployment, configuration and pilot acceptance plan
Outside the default boundary
- Automatic validation or certification
- Unscoped migration and integration
- Safety, regulatory or manufacturing depth not named in the pilot
Evidence used to judge success
- The selected workflow runs with attributable roles and lifecycle rules
- Evidence and follow-up remain linked to the originating record
- The customer can review export, recovery and qualification boundaries
Fit before transformation
Bring the workflow that is hardest to defend today.
Describe the current tools, roles, lifecycle, evidence and deployment constraints. We will identify a bounded first engagement and state plainly where the product is not yet a fit.