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“Data integrity is a fundamental element of a pharmaceutical quality system and has a direct impact on product-related decisions and traceability.  Accountabilities for ensuring data integrity run throughout an organization, from product development, through manufacture and testing, to product distribution and safety monitoring.” ISPE Special Report: Data Integrity (Mar – Apr 2016).

The importance and amount of data being generated to ensure product quality and patient safety continues to grow. Regulatory agencies are noticing a significant increase in data integrity issues, and drug manufacturers have been warned to protect the integrity of their data to meet regulatory requirements.  Proper controls around data integrity must be enforced and constantly re-evaluated.

The style and focus of regulatory pharmaceutical inspections has seemed to change almost overnight. The new focus is on data integrity. A surprising development is almost all regulators are unified in their focus and renewed application of GDP ALCOA concepts to cGMP.

Attributable – Legible – Contemporaneous – Original – Accurate

In recent years, FDA, MHRA, WHO and Health Canada have authored draft guidance and standards governing the expectations for future inspections. Brevitas can help you weather the storm of Data Integrity focused inspections with our service offerings.

  • Mock Audits
  • SDLC Review
  • Vendor Audits
  • Validation Review
  • Gap Analysis
  • Program Prevention & Detection
  • Distinct Cloud & SAAS Validation Strategy Development
  • Identity & Security Plan Development
  • Remediation Plan Development
  • System/Software Upgrades
  • Validation
  • Quality Agreement Development
  • Procedural Controls
  • Training