> Data Integrity & Data Governance

Data Management Strategies

Novo Compliance’s empowers our clients and the life sciences industry assistance architecting robust data management strategies that transform fragmented datasets (strained metadata, disparate clinical v. third-party DBs, incompatible data formats, mixing of synthetic v. real-world data, structured v. unstructured data, etc.) into harmonized, high-value assets. Novo Compliance’s approach integrates FAIR principles, regulatory alignment (e.g., GxP, GDPR, HIPAA), and scalable infrastructures providing and ensuring secure, interoperable, and audit-ready data environments across R&D, clinical trials, and post-market surveillance. By embedding semantic modeling, metadata governance, and real-time analytics, we empower organizations to unlock insights, accelerate decision-making, and maintain compliance in a rapidly evolving digital landscape.

Data Integrity

  • ALCOA + (Complete, Consistent, Enduring & Available)
  • Fit for Purpose Evidence
  • Risk Based Proportionality
  • End to End Traceability
  • Hierarchy of accountability and responsibilities

Data Governance Processes

  • Data Stewardship
  • System Validation & Life Cycle Management
  • Audit Trails and Unalterable Logging
  • Data Lineage and Sources
  • Data Transformations and Algorithm security
  • Encryption, Integrity Checks and Cybersecurity
  • Encryption, Integrity Checks and Cybersecurity

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