CoGenyx is a principal-led consultancy focused on facilities, utilities, and equipment (FUE) and their computerized systems for biopharmaceutical and cell therapy manufacturers. The work includes commissioning and qualification, computer system validation, manufacturing readiness, and investigation, CAPA, and change-control support within the client’s quality system.
Meet the principal
Robert’s life sciences career began in research in 1999, followed by industrial process development. He entered cGMP manufacturing operations in May 2009, progressing from hands-on production roles to technical operations and biologics operations supervision through 2018.
His commissioning, qualification, and validation (CQV) and computer system validation (CSV) responsibilities began in 2014. CQV consulting became his primary specialty in 2018, and he has led CoGenyx since 2024.
His CSV experience includes DeltaV configuration verification against functional specifications, data integrity and data security risk assessments, and validation of automated PLC/HMI systems. This background informs the planning, testing, investigations, and evidence review he brings to client work.
CoGenyx uses a CSA-informed approach grounded in Computer Software Assurance principles to focus assurance effort and retained evidence according to intended use and risk. FDA’s current CSA guidance is specifically scoped to the medical-device context. For biopharmaceutical and cell therapy engagements, CoGenyx applies relevant risk-based assurance principles within applicable GxP requirements, the client’s quality system, and approved procedures. Applicable requirements, including 21 CFR Part 11 where relevant to electronic records and signatures, are assessed within the agreed scope. Explore our CSV approach.
The principles that guide every engagement.
Effort reflects what failure could affect: patient safety, product quality, data integrity. The level of testing and documentation reflects intended use, risk, available knowledge, and applicable requirements within the client’s quality system.
Acceptance criteria, test cases, and root-cause analyses consider alarm behavior, failure modes, and how operators use the equipment. Vendor documentation is reviewed alongside intended use, operating conditions, and evidence from testing.
Protocols, investigations, impact assessments, and turnover packages document the basis, results, discrepancies, and disposition needed for client review. Traceability connects the requirements, testing, and retained evidence.
The principal carries the agreed scope through planning, execution, and closeout, coordinating with the client’s designated reviewers. Responsibilities, interfaces, and the review path are agreed before work begins.
Fit, schedule, dependencies, and delivery limits are discussed when defining the scope. Emerging concerns are raised with the client so priorities, responsibilities, and next steps can be agreed.
Work is planned around manufacturing readiness and the evidence needed for client review. During production, investigation, CAPA, and change-control support help maintain control of qualified systems.
Our role
CoGenyx can support a bounded work package or augment a larger program with agreed responsibilities and deliverables.
We coordinate with the client’s engineering, quality, operations, vendors, and project leadership so the work fits the project’s established processes.
Final quality decisions, approvals, and operational release remain with the client’s authorized personnel.
View CQV servicesConnect with CoGenyx
A useful first conversation starts with the project phase, systems in scope, schedule, and support you need.
Share a high-level project overview through the inquiry form.