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§ 02.4 Data & IT

Data & IT

Computer system validation, cloud-native cGxP architecture, and the data governance that makes modern compliance possible.

Modern life-sciences organizations run on data — and so does their compliance posture. We build and validate the systems that connect quality, regulatory, and operations: validated cloud architectures on AWS and Azure, computer system validation, data governance for AI-ready datasets, and the security controls (SOC 2, HIPAA, GDPR) that regulators and customers expect.

§ 02.4.A What we deliver

Specific engagements in Data & IT.

  • 01 Software Lifecycle Development and Validation
  • 02 Information Management Systems
  • 03 Data Readiness — Curation, Labeling and Governance
  • 04 Cybersecurity
  • 05 cGxP Cloud Architecture (AWS / Azure)
  • 06 SOC 2 / HIPAA / GDPR Controls Implementation and Readiness

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