Ethical’s approach to quality, compliance, and privacy is simple: be expert, be thorough. That is why our business processes, systems, and services are compliant with all appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).
GxP Compliance and Software Validation
Business processes (GxP)
Electronic records, signatures, and audit trails (US 21 CFR Part 11)
System development and implementation methodology, including completion of documentation to required standards
System configuration, system security, and change control
Standard operating procedures (SOPs) for system operation, system management, and support
User training/coaching and training records
General system issues such as system performance, maintenance, backup and recovery, disaster recovery, data retention, and network management (ISO/IEC 27001)
Provided GAMP 5 Documentation
Validation master plan;
User Requirements Specifications;
Design and Functional Specifications;
Traceability Matrix;
Protocols and tests scripts for Installation Qualification (IQ);
