Trust |
Compliance
| Assurance
HAVCOM
Who We Are
HAVCOM was established to address a persistent gap in regulated environments: systems that are heavily documented but weakly assured.
We are a specialist consulting organization composed of validation and compliance professionals who understand regulatory intent, inspection behavior, and operational reality.
Our Core Focus
Our work centers on Computerized System Validation (CSV), Computer Software Assurance (CSA), data integrity, and qualification of on-premise, cloud, and hybrid environments.
We support systems that directly impact product quality, patient safety, and data integrity across development, manufacturing, laboratory, and enterprise operations.
How We Work
HAVCOM applies a risk-based, regulator-aligned approach grounded in GAMP 5, US FDA guidance, EU GMP, PIC/S, ICH, and evolving global expectations.
Our validation strategies are designed to be practical, defensible, and sustainable—supporting organizations beyond project completion.
Why Organizations Choose HAVCOM
Organizations engage HAVCOM for independent assurance, depth of domain expertise, and clarity in complex compliance environments.
We bridge regulatory requirements and business execution, ensuring systems withstand inspections, audits, and long-term operational use.
Our Philosophy
HAVCOM is founded on the principle that compliance should create confidence, not administrative burden.
Effective validation aligns regulatory intent, system behavior, and operational practice. Our philosophy emphasizes assurance that is explainable, traceable, and resilient under inspection—allowing organizations to scale digital initiatives without accumulating compliance debt.
Independence & Governance
HAVCOM operates as an independent validation and compliance partner. We do not sell software, infrastructure, or implementation services.
This independence ensures unbiased assessments, objective risk evaluations, and validation strategies aligned solely with regulatory expectations.
Our governance model emphasizes accountability, traceability, and inspection readiness throughout the system lifecycle.
Clients rely on HAVCOM as a third-party assurance layer that strengthens quality oversight without disrupting execution.
Where We Operate
HAVCOM supports regulated organizations across global compliance landscapes, with a focus on life sciences and regulated manufacturing environments.
Our work spans new implementations, system upgrades, cloud adoption, legacy remediation, and inspection preparedness initiatives.
- GxP IT & Infrastructure Systems
- Quality & Manufacturing Platforms
- Laboratory & Data Systems
- Enterprise & Cloud Applications
A Long-Term Compliance Partner
HAVCOM is structured for long-term partnerships rather than transactional delivery. We support organizations as systems, regulations, and digital strategies evolve.
Our role extends beyond validation—providing continuity, confidence, and regulatory alignment well beyond go-live and audits.