ENQUAL Services

ENQUAL provides senior-level quality, regulatory, and engineering support for organizations operating under regulatory scrutiny.

Our work focuses on risk containment, inspection credibility, and durable systems that stand up to FDA, ISO, and EU MDR expectations.

QMS Remediation & Inspection Readiness
ENQUAL supports organizations with quality system gaps, inspection observations, or systemic weaknesses that increase regulatory exposure. We assess QMS maturity, clarify the drivers behind recurring failures, and execute remediation plans that are defensible under FDA, ISO, and EU MDR scrutiny. The focus is inspection-ready execution—risk-based prioritization, objective evidence, and leadership governance that stands up under regulator questioning.

• Inspection readiness & internal audit / mock inspection support — targeted gap assessment, mock inspection facilitation, evidence readiness, and closure plans tied to objective evidence.
   
• Regulatory response & quality governance (483, CAPA containment, executive narrative) — 483 response strategy, containment-first execution, governance cadence, and leadership-ready messaging.
   

This work focuses on system correction and stabilization where inspection risk already exists.

Design Controls & DHF Remediation

Alignment of design documentation, traceability, and design control evidence to inspection expectations.

Regulatory Response & Governance Support
ENQUAL provides senior-level support during periods of heightened regulatory pressure—inspection findings, formal correspondence, and regulator engagement. We help leadership teams frame issues accurately, establish decision-making governance, and align containment and CAPA direction with inspection expectations. The focus is regulator-facing clarity: escalation cadence, executive narrative, and credible remediation posture aligned to both current findings and long-term compliance. 

Risk Management (ISO 14971)

Risk management framework alignment, gap remediation, and risk-based decision support for complex products.

Verification & Validation Strategy

V&V planning, sample size rationale, test strategy, and defensible evidence packaging.

CAPA & Systemic Remediation

Root cause, containment, corrective action planning, and effectiveness verification.

Supplier Quality Oversight

Supplier audits, quality agreements, escalation pathways, and remediation of supplier-driven risk.

Specialized Assessments

Including compendial purified water systems (PW/WFI) and other regulated infrastructure.

ENQUAL does not begin with predefined scopes or generic proposals. Services are scoped only after structured discovery to ensure the work is focused, defensible, and aligned to regulatory expectations.

To request a Discovery Discussion, complete the ENQUAL Discovery Intake. No proposals, pricing, or commitments are made without completed discovery.