← Analytical Development
OOS investigations and method context
Out-of-specification results carry their analytical method, batch, and historical context as a connected record so quality investigations start with full provenance.
Quality is not a parallel system
In most operations, quality management runs alongside the work it governs: a parallel system of deviations, CAPA, and change controls maintained by the QA team. Krevyos makes quality a property of the work itself, so the records inspectors care about are already there.
- Domain owner
- Head of QA · QP · Quality Operations · GxP Compliance Lead
- GxP scope
- GMP · GLP · GCP · GVP · GDP · GMP+
- Inspection frameworks
- FDA 21 CFR Part 211 · EU GMP Annex 1–22 · WHO TRS · PIC/S · ICH Q9/Q10/Q12
Capabilities
Deviation management with ICH Q9 risk
Deviations captured against the product, batch, and process they affect with ICH Q9 risk framing applied as the deviation is recorded rather than as a retrospective exercise.
- Deviation management
- ICH Q9 risk
CAPA with effectiveness review
Corrective and preventive actions linked to the deviations, complaints, and audit findings that triggered them with effectiveness review as a structural property of the action.
- CAPA
- Effectiveness review
Change control per ICH Q12
Change controls structured per ICH Q12: established conditions, post-approval change management protocols, and the regulatory implications attached to the change as it's evaluated.
- Change control
- ICH Q12
Complaint handling per ICH Q10
Product quality complaints captured with link to PV adverse events where they overlap so the investigation has both the quality and safety context at once.
- Complaint handling
- ICH Q10
GxP training and competency records
Training records held against the procedures, roles, and people they govern so a competency claim is queryable, not assembled for inspection.
- GxP training
- Competency records
Audit readiness as a steady state
Inspection-ready records maintained as the system runs: 21 CFR Part 11 audit trail across every action, available on demand rather than prepared for an arrival.
- Audit readiness
- 21 CFR Part 211
Touchpoints
→ Regulatory Affairs
Change control to variation triggers
When a change control implies a regulatory action, the variation work surfaces with the affected territories and dossiers already in view.
↔ Pharmacovigilance
Complaints and adverse events
Product quality complaints and safety reports often describe the same underlying event. Krevyos handles them together so neither investigation loses the other's context.
↔ Organizations & Resources
Supplier quality and audit findings
Supplier audit findings, qualifications, and quality agreements live alongside the suppliers they govern: change controls at a partner site flow into the operation as they happen.
← Product Design
Process risk carried into production
Risk assessments from development carry into the validated process so post-launch quality work inherits the design history rather than rediscovering it.
Outcomes
- −60%(indicative)
Time from deviation detection to closure
The deviation enters the system with its context already attached: investigation, risk framing, and CAPA proposal happen on connected data.
Inspection prep time
Records inspectors look for are already maintained as part of how the operation runs: readiness is a steady state, not a sprint.
- 100%(indicative)
Actions traceable to their triggering event
Every CAPA, change control, and quality decision carries the deviation, complaint, or finding that triggered it: full ICH Q9 traceability.
- +3×(indicative)
Change controls evaluated in parallel
The connective intelligence handles the cascade work: quality teams evaluate the substance of changes, not the bookkeeping of them.
Figures marked indicative are directional benchmarks against comparable generics operations; per-customer numbers replace them in working sessions.
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Same foundation under every domain. A conversation usually clarifies where to start.