Computer Software Validation

eDSMB® Validation Package Provides Proof of Compliance

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);
• Operational Qualification (OQ);
• Performance Qualification (PQ) acceptance phases;
• Change Management, Backup and Recovery SOPs;
• User Access SOPs and procedures.