Quality assurance and compliance
Quality Assurance and GVP Audit Consulting for Global MAHs and Sponsors
GPLACO SOLUTIONS provides Pharmacovigilance Quality Assurance and GVP audit consulting for global MAHs, Sponsors, and CROs seeking FDA, EMA, MHRA, TGA and PMDA ready compliance. Our services are designed based on organizations preparing for regulatory inspections, due diligence, and partner audits, with a strong focus on risk-based GVP audits, robust PV QMS and PSMF oversight, vendor and CRO audits, and inspection readiness programs. With deep expertise across EU GVP Modules, FDA PV expectations, MHRA inspections, and ICH standards, we help decision-makers eliminate critical findings, strengthen safety governance, and maintain continuous inspection readiness across global pharmacovigilance operations.
Optimizing the Quality Lifecycle through Automation
Inspection-Ready GVP Quality Systems
Regulators do not assess intent — they assess evidence, governance, and control. Our Quality Assurance and GVP Audit Consulting model is built around how inspectors think, not how SOPs are written. We help organizations design and operate robust PV Quality Management Systems (QMS) covering SOPs, work instructions, metrics, deviation management, CAPAs, and management oversight. Every system we implement is aligned to EMA GVP Module I, FDA expectations, and MHRA inspection trends, ensuring your organization is inspection-ready at all times — not just before audits.
Quality Management System (QMS) & SOP Frameworks
Designing and authoring "Inspection-Ready" Quality Management Systems (QMS) and SOPs tailored to your operational scale and complexity. We design Quality Management Systems that guarantee 100% GVP Compliance across all safety operations, from case processing to aggregate reporting.
Independent GVP Audits for MAHs, Sponsors and CROs
We conduct risk-based, inspection-grade GVP audits across global pharmacovigilance systems, affiliates, license partners, distributors, service providers (CROs, Consulting firms and Database technology vendors), and partners. With 200+ GVP audits executed and zero critical findings, our audits go beyond checklist compliance to identify systemic risks regulators actually cite.
GVP Inspection Readiness
Outsourcing does not outsource accountability. We support vendor qualification, SDEA/PVA design, Safety management plan, audit execution, and ongoing oversight, ensuring third-party compliance aligns with your MAH responsibilities under EMA GVP, FDA and MHRA regulations.
RCA, Deviation, CAPA & Inspection Remediation Strategy Management
Regulatory findings escalate when organizations treat deviations as isolated events. We design end-to-end deviation and CAPA frameworks that regulators trust — covering root cause analysis, effectiveness checks, trend monitoring, and senior management oversight. Our remediation strategies are inspection-tested, not theoretical, and aligned with FDA warning letter patterns and EMA inspection outcomes.
Due Diligence for Vendor & Partners
Our due diligence assessments identify hidden PV and QA liabilities before they become regulatory findings or deal blockers. We evaluate inspection history, QMS maturity, safety data integrity, and compliance gaps to protect enterprise value. Specialized auditing of CROs and PV Vendors to ensure your external partners maintain the same high compliance standards as your internal team.
Strategic Risk-Based Audit Planning
AI-Driven Audit Strategy: We leverage AI to analyze historical compliance data, previous audit findings, and cross-functional risk assessments to develop a prioritized, high-impact audit schedule.Adaptive Monitoring: Our ML algorithms continuously evaluate real-time compliance metrics, allowing for dynamic adjustments to the audit strategy based on emerging risks, organizational changes, or new regulatory signals.
QPPV Compliance Metrics & KPIs oversight
Monitoring Pharmacovigilance compliance data and submission timelines to provide real-time visibility into the health of your safety system. Effective Quality Assurance requires clear accountability at the leadership level. We support QPPV oversight models, Management Review frameworks, audit committees, and governance structures that demonstrate continuous control to regulators. Our approach ensures that senior leadership can defend the PV system with confidence during inspections.
Data Integrity & GxP Security Oversight
ALCOA+ Compliance: Ensuring all safety data remains Attributable, Legible, Contemporaneous, Original, and Accurate through automated audit trails and rigorous data mapping.System Validation: We provide oversight for CSV (Computer System Validation) and 21 CFR Part 11 compliance, utilizing AI to detect unauthorized data modifications or system anomalies that could compromise the safety database.
Advantages of AI/ML-Enabled QA and Compliance
Transforming Quality Assurance with Innovative AI/ML Solutions
Our framework moves beyond traditional retrospective reviews. By implementing Real-Time Quality Intervention, we utilize automated surveillance to flag compliance deviations the moment they occur.
We transform historical data into future protection. Using Predictive Compliance Analytics, we identify patterns that indicate potential system stressors before they lead to a late submission or a quality finding.
Anticipating equipment maintenance needs reduces downtime and associated costs.
We utilize Intelligent Automation to streamline the compilation and modernize your QMS Development with these AI-driven tools, we reduce human error and ensure that your documentation is always accurate, synchronized, and ready for a 'snap' inspection by health authorities.
PV Quality Assurance and GVP Audit Consulting
GVP Audits, Vendor Oversight & Due Diligence