FDA Data Integrity

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FDA Data Integrity

FDA Data Integrity Consulting, Support & Services

At Isha’s GMP Consultancy, we ensure GxP Data Integrity compliance, which is critical for patient safety and regulatory adherence. Our high-quality Data Integrity Risk Assessments help pharmaceutical companies meet global regulatory requirements, including FDA (21 CFR Part 11), EMA, and MHRA standards.

Our Expertise in Data Integrity Includes:

  • Risk Assessments & Compliance Audits
  • Qualification of instrumentation
  • Validation of software applications
  • Verification of custom fields & calculations
  • Data security auditing & accountability
  • Isha’s GMP Approach to Data Integrity
  • Data Flow Diagram Generation: Mapping systems and identifying risk areas
  • ALCOA+ Compliance: Ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
  • Auditing & Data Traceability: Ensuring transparency and accountability

Paperless Validation Lifecycle Management Systems

Our paperless validation lifecycle management solutions ensure seamless compliance by implementing:

  • Error-Free Risk Assessments & Protocol Execution
  • Access Control & Segregation of Duties (SoD) – Ensuring appropriate system access
  • Audit Trail & Transaction History – Compliance with 21 CFR Part 11 & Annex 11
  • Centralized Repository – Secure SaaS cloud-based storage with encryption
  • Automated Review & Approval Processes – With electronic signatures
  • Integrated Change, Deviation & Risk Management
  • Controlled Validation Execution – Ensuring real-time user authentication
  • Electronic Signature & Audit Logs – Timestamped execution tracking
  • Secure Attachment of Evidences – Eliminating missing or incorrect records
  • Document Management System – Centralized retrieval, archival & retention

By implementing these solutions, Isha’s GMP Consultancy ensures that pharmaceutical and biotech companies meet FDA, EMA, and MHRA data integrity standards while optimizing efficiency, security, and compliance.

FDA Services