Execution |
Compliance
| Continuity
HAVCOM
Depth of Execution
13+ Years of Delivery
Continuous engagement in regulated environments across pharmaceuticals, life sciences, and GxP-governed operations.
100+ Engagements
Validation, assurance, remediation, and inspection-driven programs executed across diverse system landscapes.
End-to-End Coverage
ERP, QMS, LIMS, DMS, LMS, serialization, custom GxP systems, and regulated infrastructure.
Enterprise ERP Upgrade & Manufacturing Expansion
A pharmaceutical organization upgraded its enterprise ERP platform and extended the solution to a GxP-regulated manufacturing site, introducing new data integrity, integration, and operational risks.
HAVCOM performed impact assessment, system classification, and risk-based validation planning aligned with GAMP 5 and CSA principles, ensuring focus on quality-critical functionality.
The engagement resulted in inspection-ready documentation, clear traceability, and a defensible validation posture supporting long-term system use.
Greenfield Manufacturing Site – CSV Program
A newly established manufacturing facility required a complete CSV framework across laboratory, quality, and production systems.
HAVCOM designed a site-wide validation strategy covering vendor qualification, system risk assessments, validation execution, and closure governance.
The site achieved operational readiness with a structured, inspection-aligned compliance baseline supporting future expansion.
Cloud Infrastructure Qualification for GxP Systems
Critical laboratory and quality systems were migrated to a cloud-based infrastructure, introducing shared responsibility and governance considerations.
HAVCOM conducted infrastructure risk assessment, supplier evaluation, and qualification planning aligned with regulatory expectations for cloud environments.
The resulting qualification approach provided audit-ready evidence without unnecessary documentation overhead.
GxP Systems Gap Assessment & Inspection Readiness
Ahead of planned regulatory inspections, an organization required an independent assessment of its computerized systems.
HAVCOM performed system-specific gap assessments covering validation status, access controls, audit trails, and data integrity controls.
Prioritized remediation planning enabled inspection readiness with clarity, focus, and regulatory confidence.
Built on Trust
Client names and project-specific details are intentionally omitted due to confidentiality obligations. Additional experience references are shared through direct, professional engagement.