Data Integrity Assurance

Is your data compliant with ALCOA++ requirements?

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

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.

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.

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.

Ask us anything.

We have 20+ years of experience, nothing can really scare us.

Data Integrity Assurance

Don’t risk losing quality.

Data Integrity Governance

Computer System Validation

We know what we are doing.

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Whitepaper

Free Webinar

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