IT for Medical Devices & BioTech

Electronic records and electronic signatures in FDA-regulated environments require specific technical controls — validated systems, audit trails, access controls, and signature manifestation. We implement Part 11 compliant infrastructure and document the evidence your FDA inspectors and notified bodies expect.

GMP, GLP, and GCP environments require that IT systems supporting regulated activities be validated. We execute Installation Qualification, Operational Qualification, and Performance Qualification — producing the validation deliverables and change control documentation required by your Quality system.

ALCOA+ data integrity is non-negotiable for clinical data, laboratory records, and manufacturing execution systems. We implement tamper-evident storage, complete audit trails, immutable backups, and the access controls that demonstrate data integrity to FDA, EMA, and ISO auditors.

Medical device and BioTech companies handling PHI in clinical trials, post-market surveillance, or connected devices must meet HIPAA Security Rule requirements. We implement the administrative, physical, and technical safeguards HIPAA requires and maintain the audit evidence for inspections and Business Associate agreements.

Many Houston biotech companies collaborate with MD Anderson, Baylor College of Medicine, Methodist, and other TMC institutions. We build secure data exchange, federated access, and collaboration infrastructure that satisfies institutional review boards and research data use agreements.

LIMS, ELN, chromatography data systems, sequencing platforms, and manufacturing instrumentation all need secure network integration and regular backups. We support integration with Empower, LabVantage, Benchling, and the instrument-specific systems your lab depends on.