Accelerate Phase 2 trial readiness
CDMO onboarding up to 50% faster
search 40+ SME interview transcripts
Quality Governance: Human Accountability & Responsibility Matrix
This page establishes the organizational structure, segregation of duties, and professional qualifications of the personnel defining and enforcing the Method Made validation lifecycle. Software systems reduce execution friction, but regulatory compliance requires unyielding, qualified human accountability at every critical gate.
Executive Summary
​The Method Made Quality Governance board bridges the operational gaps between software development, laboratory process development, and clinical trials. By distributing ownership across independent lines of strategic, technical, biological, and clinical execution, the framework ensures a cross-functional, risk-based approach to software assurance that stands up directly to strict institutional and regulatory audits.
GMP Roadmap Review
Jonas Elliot Gerson MSc
(VP Operations PnuVax Biologicals CDMO)
Clinical Pipeline Integration & Advisory
Rishi Chavan MD
(Medical Director at Children's Hospital of Orange County)
Mandate: Evaluates the overarching, risk-based compliance roadmap. Jonas’ deep professional history leading GMP operations within a highly regulated CDMO environment provides the strategic foundation required to pre-vet the GAMP 5 product lifecycle before technical execution begins.
Mandate: Provides high-level guidance on clinical deployment, patient access realities, and process safety loops. Dr. Chavan’s extensive clinical practice and research history in cell therapies and pediatric oncology ensure that the software architecture maps seamlessly into complex clinical trial operations and institutional workflows.
Document Author
Nicholas (Nico) Crudele MSc
(previous quality laboratory director Driftwood Brewery)
Domain SME
Ziuwin Leung Msc
​
(process development engineer at Nomic Bio)
Technical Verification Lead
Muhammad Afaq​
​
(software quality assurance engineer at Shikkra Tech)
Document Author
Nicholas (Nico) Crudele MSc
(previous quality laboratory director Driftwood Brewery)
Domain SME
Ziuwin Leung Msc
​
(process development engineer at Nomic Bio)
Technical Verification Lead
Muhammad Afaq​
​
(software quality assurance engineer at Shikkra Tech)
Mandate: Originates the core technical architecture, drafting standard operating procedures (SOPs), Master Batch Records (MBRs), and Electronic Batch Records (EBRs). Nico’s background building and overseeing comprehensive quality management systems in high-throughput, contamination-sensitive environments anchors the technical instructions in absolute data integrity.
Mandate: Conducts thorough, data-driven reviews of all validation package supporting documents. Zwin's domain expertise in laboratory process development forces the software logic to accurately respect and mirror the real-world physical and biological variables seen on the manufacturing floor.
Mandate: Acts as the primary micro-gatekeeper for code execution. Muhammad's dedicated background as an independent software quality assurance engineer qualifies him to pre-approve test parameters, independently execute technical verification protocols, audit system records, and deliver the final QA sign-off to freeze the system baseline at the code level.