Data Integrity Assurance

I tuoi dati sono allineati ai requisiti ALCOA++?

Non rischiare sulla qualità.

I dati sono una parte fondamentale di ogni ciclo di produzione Lifescience e sono diventati oggetto di attenzione da parte degli enti regolatori di tutto il mondo.

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

Sappiamo quel che facciamo.

Accedi al materiale preparato dal nostro team di esperti.

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.

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Abbiamo più di 25 anni di esperienza nel settore. Nulla può spaventarci.