Continuous quality monitoring is the defined, recurring review of approved quality sources for relevant changes, discrepancies, deadlines, missing evidence, and expiring records. When Ovada finds a potential issue, it gathers the available evidence and routes the finding to the right qualified person.
How it differs from a point-in-time assessment
An audit or gap assessment is a snapshot. Afterward, procedures are revised, CAPAs change processes, supplier records expire, and new FDA 483s reshape how you read risk.
Continuous monitoring checks approved sources over time using defined triggers or schedules. Learn more about continuous quality monitoring with Ovada.
What can be monitored
- Changes to approved procedures
- Contradictions between procedures or records
- Missing evidence and overdue tasks
- Expiring supplier documentation
- Unresolved quality events
- Changes introduced by CAPAs
- Training impacts
- Relevant FDA 483 observations
The monitored scope must be explicit. Ovada does not watch every system, record, or person by default.
SOP revisions+ Regulatory updates+ CAPAs+ Change controls
Owner reviews → Signs disposition
What happens when Ovada finds a potential problem
A useful finding is more than an alert. Ovada prepares:
- A plain-language description of the issue
- The source evidence
- The requirement or expected condition
- Missing or conflicting information
- The affected workflow or record
- The recommended next review step and owner
Examples of findings
- A revised procedure conflicts with another active document, with both passages cited
- A supplier qualification record is incomplete or expiring (supplier quality management)
- A CAPA changed a process that related documents do not yet reflect (CAPA management)
- A deviation record still lacks required evidence (deviation management)
A potential discrepancy is not always a compliance failure. Qualified people decide whether sources truly conflict, what risk the finding creates, and what to do.
How to define a monitoring workflow
Specify the approved sources, the trigger or schedule, the conditions checked, the evidence to keep, the routing rules, the responsible reviewer, and where the record goes. Without those, “continuous monitoring” is a slogan instead of a repeatable quality process.
Questions
Is continuous monitoring always running?
It runs on the triggers and schedules defined for each workflow, such as a document revision, a new record, an approaching date, or a recurring check.
Does a monitoring finding mean we are out of compliance?
Not necessarily. A finding is a potential issue with its evidence attached. Qualified people decide whether it is real, what risk it creates, and what action to take.