Validation |
Assurance
| Compliance
HAVCOM
Computerized System Validation (CSV)
End-to-end validation aligned with GAMP 5, US FDA, EU GMP, PIC/S, and ICH expectations across the system lifecycle.
Computer Software Assurance (CSA)
Risk-based assurance strategies focusing on critical functionality, patient safety, product quality, and data integrity.
Cloud & Infrastructure Qualification
Qualification of on-premise, IaaS, SaaS, and hybrid environments, including shared responsibility and supplier oversight models.
Digital Quality & GxP Systems
Validation and compliance support for QMS, LMS, DMS, LIMS, ERP, serialization, and custom GxP applications.
Data Integrity & ALCOA+
Data integrity risk assessments, control design, and remediation aligned with ALCOA+ principles.
System Risk Assessments
Risk-based classification and impact assessments supporting defensible validation and testing strategies.
Legacy System Remediation
Assessment and remediation of legacy systems to address gaps in validation, documentation, and controls.
Audit & Inspection Readiness
Mock audits, gap assessments, and inspection support aligned with current regulatory inspection practices.
Change & Periodic Review Support
Change impact assessments and periodic review frameworks ensuring ongoing compliance post go-live.
Vendor & Supplier Qualification
Supplier assessments and qualification activities supporting GxP system and service provider oversight.
Our Delivery Model
HAVCOM delivers services through a structured, risk-driven model designed for regulated environments where accuracy and traceability are critical.
Each engagement is tailored to system criticality, regulatory impact, and organizational maturity—ensuring compliance activities are proportionate, defensible, and sustainable.
What Clients Can Expect
Regulatory Alignment
Validation and assurance activities aligned with current regulatory guidance and inspection expectations.
Clear Documentation Strategy
Documentation that supports compliance decisions without unnecessary complexity or redundancy.
Practical Execution
Solutions designed for real operational environments, not theoretical compliance models.
When to Engage HAVCOM
Organizations engage HAVCOM during critical system transitions where compliance risk must be actively managed.
Our services support both proactive planning and corrective remediation across the system lifecycle.
- New system implementations
- Major upgrades or migrations
- Cloud adoption initiatives
- Inspection or audit preparation
Assurance Beyond Delivery
HAVCOM’s services are designed to provide confidence beyond project completion. We focus on creating compliance frameworks that remain effective as systems, regulations, and organizations evolve.
Our role is to reduce regulatory uncertainty and support long-term inspection readiness.