Data Integrity Assurance

Is your data compliant with ALCOA++ requirements?

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Don’t risk losing quality.

Data is a fundamental part of any Lifesciences production cycle and has become a major concern for global regulatory authorities.

Choose PQE Group and ensure patient safety and business continuity within the entire product life cycle.

Data Integrity Governance

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

Computer System Validation

  • Computer System Validation Strategy
  • Best Practices for Cost Saving & Quality of 21 CFR Part 11 Compliance Strategy
  • Validation Templates and System Specific Packages
  • Ongoing Adaptation of Risk Based Computer Validation Approach to Current Regulatory Expectations
  • Computer Validation of Global and Local IT Systems (e.g. ERP, MES)
  • Laboratory & Process Control Systems Validation
  • CSV Best Practices
  • User Requirements and Process Mapping
  • Data Migration Verification Strategy and Execution
  • System Testing (Unit & Integration Tests, UAT)
  • Validation Test Planning, Execution & Documentation
  • Best Practices Procedures to Maintain the Validated Status
  • Change Management & Periodic Review
  • 21 CFR Part 11 & EU GMP Annex 11 Assessments
  • Risk-prioritized & Turnkey Remediation Projects
  • 21 CFR Part 11 Inspection Readiness Projects

Our Software Partners
for Validation

Kneat
ValGenesis

We know what we are doing.

Don’t believe us? Check out the material put together by our team of experts.
Video
Watch PQE’s Vice President Executive Danilo Neri explaining in less than five minutes the alluring benefits your business can achieve by investing in Data Integrity.
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Whitepaper
Read the complete guide written by PQE’s CEO & Founder Gilda D’Incerti about current quality guidelines and the emerging trends in regulatory expectations.
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Free Webinar
Browse our Knowledge Gallery and view our free online webinar about Data Integrity Governance as a Quality System among many other on-demand webinars.
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