Quality Systems & eQMS
Capabilities
QMS development, eQMS implementation (Veeva Vault), SOP lifecycle, UAT, record migration, and data reporting.
Frameworks
GMP/GxP, 21 CFR Part 11 requirements for electronic records, and computerized system validation principles.
Deliverables
SOPs, workflow requirements, system test docs, process maps, training materials, and reporting frameworks.
Deviations, CAPA & Quality Ops
Quality events require timely investigation, defensible root cause analysis, and corrective actions supported by clear documentation. QOVA provides technical quality support to help organizations manage investigations, strengthen CAPA processes, and address recurring operational issues.
Core Capabilities
• Deviation and nonconformance investigations
• Root cause analysis (RCA)
• Corrective and preventive action (CAPA) development
• Quality-event trending and analysis
• Investigation report writing
• Change control support
Further Quality Support
• Quality documentation remediation
• Quality metrics and process improvement
• Audit preparation and readiness
• Quality-process mapping
• SOP and work instruction development
• CAPA review and documentation support
Technical Basis
GMP/GxP, pharmaceutical quality-system principles, and applicable quality risk management practices.
Key Deliverables
Investigation reports, root cause assessments, CAPA plans, quality-event trend analyses, revised procedures, and remediation documentation.
Validation & Qualification
Services & Capabilities
Regulated systems require documented proof of performance. QOVA supports your needs through planning, technical execution, and controlled documentation.
Core Qualification Services
- Equipment IQ, OQ, PQ
- CSV & URS
- Validation Plans/Protocols
- Traceability & Reports
- FAT/SAT
- Environmental Mapping
Technical Frameworks
Applying GMP/GxP, 21 CFR Part 11, and risk-based CSV to deliver plans, protocols, test records, and summary reports for audit readiness.
Audit & Inspection Readiness
1
Readiness Assessments
Review systems, documentation, and practices to understand current readiness and define the work required to prepare.
2
Mock Audits
Simulate audits or inspections, identify gaps, and support the follow-up work needed to close them.
3
Supplier Oversight
Clarify expectations, documentation, and oversight for critical suppliers so external partners support your quality and operational standards.
Operational Systems & Support
QOVA helps design and strengthen the systems that keep operations moving—from process mapping to planning, handoffs, and ongoing improvement.
Map and clarify key processes so responsibilities, handoffs, and decision points are visible and actionable.
Assess where operational systems, documentation, or ownership are limiting performance or growth.
Design practical workflows and controls that teams can follow in real conditions.
Provide project and implementation support so planned changes are actually carried through.
Strengthen production planning and critical handoffs so work moves smoothly between teams and vendors.
Support continuous improvement of systems and processes as the organization grows.