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Compliance and Security

Compliance and Security Standards

Fully compliant with regulations and security standards

FDA 21 CFR Part 11, GDPR, HIPAA, and GAMP 5 compliance

GAMP 5, cGMP, COI, and COC

Intuitive configuration that provides compliance with cGMP

Complete and easy to retrieve audit trails

Data security and data integrity

Personal data encryption and masking

Cloud security provided by the world's leading provider (Amazon)

Dedicated and isolated database for each customer to ensure confidentiality, security, and integrity

Data Integrity and Compliance

Data Intregrity and Compliance.png

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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