Full PV adverse event intake system: AE Connect
Full pharmacovigilance adverse event intake system, built as AE Connect (aeconnect.io), a product of QORO Intelligence Inc. Scope covers end to end adverse event intake for pharmacovigilance teams.
Veeva Vault and quality systems case studies
Full Veeva Quality Suite implementation
Led the design and implementation of the Veeva Quality suite as hands on project lead, from requirements through configuration and go live. Served as CSV lead and Veeva Quality SME, building a compliant foundation for the company's quality systems, and performed independent vendor audits to support supplier qualification. Experience across the full Veeva Quality suite includes designing and leading a Veeva Vault QMS implementation from requirements through validation and go live, and the initial implementation and validation of Veeva Vault QualityDocs.
Veeva PromoMats: FDA Form 2253 and MMRC, PRC, GRC enablement
Implementation and validation of the Veeva PromoMats FDA Form 2253 submission capability, plus configuration of PromoMats to enable MMRC, PRC and GRC review.
Commercialization readiness: systems and processes stood up
Stood up commercialization systems and processes, including a Medical Information hub, TraceLink, SLIMStat, post market adverse event monitoring, batch disposition, supplier qualification management, and internal and external audit management.
Paper based quality systems migrated into electronic systems
Built GxP Quality Systems from the ground up, then moved paper processes into validated electronic systems: digitizing Change Control, Deviation, CAPA, and Internal and External Audit Management in Veeva Vault QMS, and establishing controlled document management and approval workflows in Veeva Vault QualityDocs.
eTMF implementation and controlled migration
Veeva eTMF implementation and validation, plus controlled migration of trial master file content into eTMF from three kinds of source: another eTMF, Box and SharePoint.
Multi Vault rollout: eTMF, CTMS and RIM
Led validation and implementation of Veeva eTMF, CTMS and RIM, coordinating requirements, configuration and testing across clinical and regulatory stakeholders. Authored and executed validation deliverables under a risk based approach aligned with 21 CFR Part 11 and GAMP 5, supporting compliant go live.
Veeva RIM configured for BLA submission readiness
Served as Veeva RIM administrator for day to day operational use. Designed and delivered RIM configurations tailored to business needs, enabling the regulatory team to plan, manage and support BLA submissions.
Veeva and CSV partnership
QFS supported this client across a long term engagement on Veeva eTMF, RIM, the entire Veeva Quality suite and PromoMats, managing ongoing systems maintenance and computer system validation, including change control, release impact assessments and maintaining the validated state.