Data
Integrity
Assurance

Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.
Choose PQE and ensure patient safety and business continuity within the entire product life cycle.

Discover our solutions

Data Integrity

Data Integrity

The key action to design a compliant quality system to manage regulated Data.

Computer System Validation

Computer System Validation

The best practices for validating and monitoring your computerized systems.

Is your data ALCOA+?

A number of hidden potential violations may already be embedded in your current processes.
Don’t risk losing quality and trust: choose the right training, guidance and support.

  • Assess and evaluate risks
  • Validate your system
  • Avoid observations and enforcements actions
  • Prevent impacts on business operations
  • Ensure that all data is compliant to the newest regulations
  • Achieve growth and success
ALCOA+ meaning

Want to know more?

Video

Watch PQE’s Vice President Operations and PhD Danilo Neri explaining in less than five minutes the alluring benefits your Business can achieve by investing in Data Integrity.

Data Integrity Paper

Whitepaper

Read the complete guide written by PQE's founder and CEO Gilda D’Incerti about current quality guidelines and the emerging trends in regulatory expectations.

Data Integrity Webinar

Webinar

Browse our Knowledge Gallery and view our free online seminar about Data Integrity Governance as a Quality System among many other on-demand webinars.

Life Science Product Regulatory Life Cycle

Why PQE?

PQE Group, with multidisciplinary teams with 20+ years of extensive experience and scalable delivery model based on a robust risk analysis, has an unmatched record of supporting clients in turnkey validation projects with FDA, EMA, WHO, COFEPRIS, GILS, TGA, SSA, SFDA, ANVISA, INVIMA and other regulatory authorities.

We can support you in every phase of the product lifecycle, assuring Data Integrity throughout all steps of the process, from Clinical Trials to Pharmacovigilance.

Full Service Portfolio

Data Integrity Full Service Portfolio

  • 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 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, LIMS, 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

A quality-driven approach to Data Integrity

In November 2016, Gilda D'Incerti, CEO and Founder of PQE Group, presented our vision and methodology regarding the protection of Data at the FDA News meeting, speaking about the differences between the European market and the US market.

We would love to share her speech with you.

Get in touch.

We will be more than happy to help you find the most suitable solution for your business.