Computer Software Validation

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.