Ethical Software is developed, released and maintained following the Good Practice (GxP) regulations of FDA and EMA

Ethicalvalidation

Ethical software services, handling electronic records invoved in clinical processes or quality system (or that are used to create and maintain records required by any other GxP regulation) are subject to the US Code of Federal Regulation Electronic Records and Signatures regulation (FDA, 21 CFR Part 11) and are compliant to the EU GMP Vol. 4 Annex 11.

Ethical Systems and Services are compliant with regulations (GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11) :

  • Business Processes (GxP),
  • Electronic records, signatures and audit trails (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 27001).

Full GAMP 5 Validation documentation package and support are provided (if required) 

 

  • Validation Master Plan, User Requirements Specifications, Design and Functional Specifications, Traceability Matrix,

  • Protocols and tests scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) acceptance phases,

  • Change Management, Backup and Recovery and Users access SOPs and procedures.

 _________________________________________________________________

INTERESTED IN ETHICAL eCLINICAL SOFTWARE & SERVICES ?