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Home - Industry 4.0 - PQE Group - Data Integrity Assurance
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Data Integrity Assurance

Data integrity may expose life science companies to significant regulatory and business risk.

PQE’s multidisciplinary teams allow customers to achieve compliance and the Data Governance System, which is integral to a fully functional Quality System.

The integrity of regulated data relies upon the validation of the computer system responsible for managing regulated data. As a proven global leader on this topic, PQE can support customers in the implementation of a cost effective and feasible validation strategy. This results in the assurance of the systems validation life cycle, which in turn enhances and improves product quality, patient safety and data integrity. PQE’s integrated approach enables client’s data integrity assurance and validation requirements through a scalable and fully regulatory compliant delivery model, based on a robust risk analysis.

Pharma Capabilities
  • Data Integrity Policy
  • Data Integrity Historical Verification
  • ALCOA Assessment
  • Data Integrity Remediation Plans
  • Continuous Monitoring Procedures for Data Integrity
  • Audit Trail Review Methodologies

Model description

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