Data Integrity

Ensuring Data Integrity

highlighting importance of regulations

Regulatory agencies around the world pay much attention to data integrity as it eliminates the need to inspect every GxP record to safeguard patient safety. A multi-tenant cloud environment brings new challenges for ensuring data integrity. Right engineering and procedural controls ensure the data is trustworthy. But how do you assure the agency they can trust your data? Brevitas can help you build a solid validation package to demonstrate the data integrity and compliance of your computerized systems. Our experienced consultants perform data integrity assessments of the computerized systems in your operating environment, identify gaps, recommend remediation actions, and help you build necessary controls.

From Product Development to Distribution and Safety Monitoring

scientist inspecting drugs for quality and safety

“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 (March – April 2016).

Overcoming Data Growth Issues

illustration indicating data growth

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.

Focus on Data Integrity

group of engineers discussing data integrity in the pharmaceutical industry

The style and focus of regulatory pharmaceutical inspections have 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.

In recent years, FDA, MHRA, WHO and Health Canada have authored draft guidance and standards governing the expectations for future inspections.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.

Data Integrity Services

Audit & Assessment


  • Mock Audits
  • SDLC Review
  • Vendor Audits
  • Validation Review
  • Gap Analysis
  • System Criticality Assessment
  • Risk Assessment
  • Periodic Review & Audit

Planning


  • Program Prevention & Detection
  • Distinct Cloud & SAAS Validation Strategy Development
  • Identity & Security Plan Development
  • Remediation Plan Development

Remediation


  • System/Software Upgrades
    Validation
  • Quality Agreement Development
  • Procedural Controls
  • Training

Let's Get Started!

Our expert consultants will guide you step-by-step through the process of achieving tangible results and long-lasting improvements.