Quality Systems & CSV
eDMS, QMS, CSV, and GxP QA Expertise ensuring Regulatory Readiness
Celito aligns technology, process, and people to create an inspection‑ready quality backbone. From Computer System Validation (CSV) to enterprise QMS rollouts, we give fast‑moving biotechs the compliance muscle of a commercial manufacturer - without the overhead.
Why Modern Quality Systems Matter
Regulators expect airtight documentation, validated systems, and closed‑loop CAPA processes at every stage from first‑in‑human to post‑approval. Yet emerging biotechs often rely on spreadsheets and siloed vendors. Celito delivers an integrated quality ecosystem so you can sail through FDA, EMA, and MHRA inspections.
What We Deliver
Quality Systems Advisory
- Comprehensive gap assessments with risk-ranked remediation roadmap aligned to regulatory expectations.
- Phase-appropriate Quality Management Plan that scales from discovery through commercialization.
eDMS & QMS Implementation
- Vendor selection, configuration, and user-adoption for electronic quality solutions.
- Document control, training, deviation, CAPA, change control, and audit modules in a single system.
- Migration of legacy SOPs and records with metadata harmonization and audit trails.
Computer System Validation (CSV)
- 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 Improvement
- Quarterly quality metrics dashboards for deviations, CAPAs, and audit observations.
- Root cause analysis workshops and Kaizen events to drive preventive actions.
- Training curricula updates and LMS integration for role‑based 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
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Model
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Typical Use Case
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Commitment
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|---|---|---|
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Quality Accelerator Program
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Series A–C needing eDMS & CSV in <4 months
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16 weeks
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Fractional QA Leader
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Interim Head of Quality & inspection prep
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1–2 days/week
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Managed Quality Services
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Operate QMS, training, and metrics
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Ongoing
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Validation Factory
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CSV packages for new or upgraded GxP systems
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Project‑based
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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.