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
The key action to design a compliant quality system to manage regulated Data.
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
A quality-driven approach to Data Integrity
In November 2016, Gilda D’Incerti, CEO and Founder of SCB Systems, 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.
Why SCB System ?
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.
Newsletter
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
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SCB Systems
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