Quality Systems & CSV Enablement
Tech-enabled eDMS, QMS, and validation frameworks enabling Regulatory Readiness
Celito enables quality operations through standardized quality systems, proprietary accelerators, and validation frameworks that provide inspection ready compliance foundations for fast growing biotech organizations without commercial scale overhead.
Why Modern Quality Systems Matter
As regulatory expectations increase from early development through commercialization, fragmented documentation and manual quality processes introduce compliance risk. Celito deploys integrated quality platforms and standardized validation frameworks that enable inspection readiness across FDA, EMA, and MHRA inspections.
What We Deliver
Quality Systems Strategy & Enablement
- Comprehensive quality system assessments with risk-ranked remediation roadmaps aligned to regulatory expectations.
- Phase-appropriate quality management models that scale from discovery through commercialization.
eDMS & QMS Platform Deployment
- Vendor selection, configuration, and user adoption for electronic quality platforms using standardized deployment frameworks.
- Integrated document control, training, deviation, CAPA, change control, and audit workflows within a unified system.
- Migration of legacy SOPs and records with metadata harmonization and audit trail preservation.
Computer System Validation (CSV) & CSA Execution
- CSA/CSV strategy aligned to FDA CSA guidance and GAMP 5.
- Full validation lifecycle - URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Release Memo.
- Validation accelerator templates reduce effort by 30 % and maintain inspection readiness.
Audit & Inspection Readiness
- Live eDMS evidence rooms with real‑time document availability.
- Day‑0–Day‑n playbooks covering logistics, data requests, and interview prep.
- Post‑inspection CAPA management and effectiveness checks.
Continuous Quality Governance & Optimization
- Quarterly quality metrics dashboards for deviations, CAPAs, and audit observations.
- Root cause analysis and preventive action frameworks embedded into quality operations.
- Role-based training programs and LMS integration supporting sustained compliance.
Our 4‑Step Methodology
Assess
Comprehensive GxP and system gap analysis.
Architect
Future‑state QMS, CSV, and data integrity blueprint.
Implement
Validated configuration, migration, and training.
Advance
Ongoing monitoring, metrics, and continuous improvement.
Flexible Ways to Engage
|
Model
|
Typical Use Case
|
Commitment
|
|---|---|---|
|
Quality Accelerator Program
|
Series A–C needing eDMS and CSV uplift
|
16 weeks
|
|
Quality Leadership Operating Model
|
Leadership plus inspection prep
|
1–2 days/week
|
|
Managed Quality Enablement
|
Operate QMS, training, and metrics using standardized runbooks
|
Ongoing
|
|
Validation Factory
|
CSV packages for new or upgraded GxP systems
|
Project‑based
|
Proven Outcomes
Clients averaged <5 minor observations across 14 inspections (2024–2025).
30% reduction in validation effort using Celito accelerator templates.
Zero data integrity findings in MHRA and FDA inspections for supported clients.
94% CAPA effectiveness rate one year post‑implementation.