Contact UsEndpoint Adjudication NewsLinkedin
X
Open/Close overlay
Endpoint Adjudication Data Safety Monitoring Boards Protocol Deviation SAE Reconciliation Contact Us

Home / GxP Compliance / Computer Software Validation

Computer Software Validation

eAdjudication® 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.

Request a Demo of the eAdjudication® Software Solution

We are EU-GDPR compliant: Your Data will never be used improperly



Download Ethical eAdjudication for Endpoint Adjudication Dossier

eAdjudication
software solution
service description

DOWNLOAD
Previous Next

Endpoint Adjudication Committees: Uppsala Clinical Research UCR provides its Feedback on eAdjudication

Uppsala Clinical Research Center (UCR), a top Academic Research Organization based in Sweden, shares its experience in using eAdjudication platform to manage the central assessment of Clinical Trial Endpoints (CEC).

Endpoint Adjudication Committees: Uppsala Clinical Research UCR provides its Feedback on eAdjudicationREAD MORE

DOWNLOAD the Endpoint Adjudication Charter Template. By the "Endpoint Adjudication" Linkedin Group 

In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.

Adjudication Charter - Download the Endpoint Adjudication Charter Template designed by the Endpoint Adjudication Group on LinkedinREAD MORE

Endpoint Adjudication: using MediData Rave Medical Records in eAdjudication

A technical approach to transfer Events and Medical Records from the Medidata Rave EDC platform to eAdjudication Software for Clinical Endpoint Adjudication.

Endpoint Adjudication: using MediData Rave Medical Records in eAdjudicationREAD MORE