Veeva Vault implementation for biotech
Veeva Vault implementation for small biotech teams, run by a hands on project lead who also owns validation.
QMS
Change Control, Deviation, CAPA, and Internal and External Audit Management in Veeva Vault QMS, from requirements through validation and go live.
QualityDocs and Training
Controlled document management and approval workflows in Veeva Vault QualityDocs, and Training added to Vault QMS.
eTMF and CTMS
Veeva eTMF and CTMS implementation and validation, including controlled migration of trial master file content.
RIM
Veeva RIM configuration to help regulatory teams plan, manage and support BLA submissions.
PromoMats
PromoMats configuration for MMRC, PRC and GRC review, and the FDA Form 2253 submission capability.
How a rollout runs
Requirements, configuration, validation, cutover and hypercare. See GxP project management and case studies.