Regulatory change monitoring
Track updates to applicable requirements and guidance, then identify which registered procedures they may affect.
Continuous quality monitoring
Continuous quality monitoring that finds the gap before the next audit does
A gap assessment shows one moment in time. Ovada keeps watching regulations, procedures, and quality records for changes, contradictions, open events, expiring documents, training gaps, and relevant FDA 483s, then routes each finding to the right person with the evidence attached.
- Regulations
- SOPs
- Training
- CAPAs
- Supplier certificates
- FDA 483s
SOP-QC-012 · revised to rev 54 analysts not yet trained on the revisionRouted to the QA lead · evidence attached
Castellan Excipients · GMP certificateExpires in 30 daysRenewal requested from the supplier
FDA 483 · peer siteOOS investigations citedChecked against SOP-QC-020 · no gap
Watching 6 sources · every finding reaches a person, with the evidence attached
Your quality system keeps changing between assessments
An audit, gap assessment, or management review shows the quality system at one moment. Then the moment passes. Start with a GMP gap assessment, then keep it current.
- Regulations and guidance are updated
- SOPs and specifications are revised
- CAPAs change related processes
- Supplier records approach expiration
- Deviations and investigations stay open
- New employees need training
- FDA 483s reveal risks that may exist internally too
What Ovada watches
Monitor regulations, procedures, and quality records
Continuous quality monitoring is configured around the requirements, procedures, systems, and sources in your approved monitoring scope.
SOP and specification changes
When a controlled document changes, check the effective version against the requirements it addresses and the procedures that depend on it.
CAPA effects
Spot when a corrective action changes related procedures, training, or supplier requirements.
Supplier documentation
Track certificates and qualification dates before an expired record becomes a finding.
Open quality events
Surface unresolved deviations, investigations, overdue actions, and training gaps.
FDA 483s and warning letters
Compare observations at peer companies with the processes in your scope.
From signal to review-ready finding
- 01
Set the monitored scope.
Define the sources, procedures, systems, owners, and conditions Ovada may watch.
- 02
Detect a change or condition.
A regulatory update, revision, contradiction, deadline, missing record, or open event surfaces.
- 03
Gather the context.
Ovada pulls the related requirements, procedures, records, dates, and events.
- 04
Route the finding.
The responsible person gets the finding with its evidence, not a bare alert.
- 05
Preserve the reviewed state.
The decision, rationale, and signature become the reference point for the next cycle.
Traditional model
- Gap assessment
- Report
- Remediation
- Wait
- Reassess later
Ovada model
- Gap assessment
- Reviewed state
- Monitor
- Detect change
- Assess impact
- Quality review
- Updated state
Know what a change actually affects
Finding a change is the first step. With continuous quality monitoring, Ovada maps it to the requirements, procedures, and prior findings that may need another look, and flags earlier findings that may no longer reflect the current state.
Structured findings6 types
- Requirements with no matching procedure
- Procedures that only partially address a requirement
- Contradictions between procedures
- Gaps between procedures and current practice
- Commitments that have not been implemented
- Training not updated after a revision
Regulatory change monitoring tells you something changed. Ovada shows what that change means for your quality system, and qualified people decide what happens next.
Frequently asked questions about continuous quality monitoring
01What is continuous quality monitoring?
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Continuous quality monitoring is the ongoing review of approved quality sources for defined changes, contradictions, missing evidence, deadlines, open events, and other conditions that need attention.
02What is GMP compliance monitoring?
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GMP compliance monitoring checks whether procedures, records, and practice still meet the applicable GMP requirements as regulations and the quality system change. Ovada combines it with quality-system monitoring so both kinds of change reach Quality with their evidence.
03How is continuous monitoring different from a gap assessment?
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A gap assessment is a point-in-time evaluation. Continuous monitoring keeps checking the approved sources after that baseline is set, so new gaps surface when they appear.
04Does Ovada make compliance decisions automatically?
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No. Ovada detects defined conditions, gathers evidence, and prepares findings. Qualified people keep judgment, disposition, authorization, and accountability.
05Can Ovada monitor FDA 483 observations?
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Yes. Ovada can monitor FDA 483 observations relevant to the processes in your monitoring scope and flag where a similar gap may exist in your own quality system.
06How often does Ovada monitor?
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Monitoring runs on the triggers and schedule defined for each workflow, such as a regulatory update, a document revision, a new record, an approaching date, or a recurring check.
Find the gap before the next audit does
Bring one quality process and see how Ovada monitors the requirements and records around it.