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Compliance and Security
Compliance and Security Standards
Fully compliant with regulations and security standards
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FDA 21 CFR Part 11, GDPR, HIPAA, and GAMP 5 compliance
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GAMP 5, cGMP, COI, and COC
Intuitive configuration that provides compliance with cGMP
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Complete and easy to retrieve audit trails
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Data security and data integrity
Personal data encryption and masking
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Cloud security provided by the world's leading provider (Amazon)
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Dedicated and isolated database for each customer to ensure confidentiality, security, and integrity
Data Integrity and Compliance
Lack of Personnel Preparedness
Human Errors and Data Integrity Deficiencies
Failure to Assess Procedures Against Requirements and Expectations
Lack of Security Controls
Lack of Document Control Processes
Malfeasance by Employees
Domain
Integrity
Accuracy Usability
Row
Count
Complete
Consistency
Validity
Redundancy
Referential
Integrity
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