Quality Assurance for GCP Clinical Trials
hVIVO runs a regulatory compliant Quality Management System (QMS) spanning clinical, laboratory, data and project operations, with risk based internal audits, service provider (vendor) assessments, quality incidents management and Root cause Analysis (RCA), CAPA oversight, and inspection support aligned to regulatory expectations (MHRA, EMA and FDA).
- GxP compliant QMS across clinical, lab, data & PMO — procedures, SOP control, quality incidents and CAPA oversight managed centrally by QA. Compliant with applicable GxP, including GCP, GCP Laboratory and GLP, as applicable.
- Risk based internal audits & service provider qualification — routine audits across all functional areas; external providers assessed against defined standards.
- Inspection ready Trial Master Files (TMF) — version controlled documents, audit trails and where applicable, independent QA review support inspection readiness.
- ALCOA+ data integrity embedded in data handling and system validation for regulatory acceptance.
Quality First Approach
Quality Management Systems (QMS)
Comprehensive, GCP compliant QMS covering clinical, laboratory, data and project operations.
Centralised SOP governance with version control, change management and controlled documentation workflows.
Audit & Oversight Platforms
Vendor qualification and ongoing oversight of CROs, laboratories, technology providers and specialist partners.
TMF & Documentation Integrity
Inspection ready TMF/eTMF infrastructure with contemporaneous filing, audit trails and controlled access.
Document versioning and metadata capture to support MHRA/EMA/FDA expectations for reconstruct ability.
Training & Competency Systems
Role-based training management platforms that track protocol training, SOP updates, and regulatory refresh cycles.
QA-led training compliance oversight to ensure every study team member is inspection-ready.
Data Integrity & Systems Validation
Application of ALCOA+ principles across all data touchpoints.
Validation and periodic review of computerized systems, including audit trails, e-signatures, and controlled permissions.
Inspection Readiness & Regulatory Support
Continuous inspection readiness through routine checks, mock inspections, and pre-inspection evidence packages.
QA support during MHRA, EMA and FDA inspections, including response management and CAPA follow up.
