Enhancing Regulatory Compliance in Global Pharmaceutical Submissions Using Veeva Vault and Digital Workflow Automation (Research Article)

Author(s): Omer Wasiq Senior Reg Ops Specialist (Freelance), Area 23 HC, New York, United States of America.

Abstract: Global pharma submissions encountered growth in complexity as QA, non-clinical, and clinical dossiers grew in size and scope to satisfy differing standards of agency submission filings (e.g., FDA, EMA, PMDA, NMPA), unequally established regulatory documentation requirements, eCTD filing formats, categorization of post-approval change types, and data expectations, heavily taxing legacy systems relying on isolated document repositories, spreadsheets, mailing lists, and manual hand-offs, causing frequent version-control errors, time-consuming impact analysis, and compromised data integrity, attributable to ALCOA+ principles. This paper reviews how Veeva Vault RIM (Registrations, Submissions, Submissions Publishing, and Submissions Archive), partnered with digital workflow automation, closes these gaps. Using a literature review, published case-study discussion, and an affinity diagram, the work finds that the platform establishes a single source of truth, streamlines content planning, and enables continuous publishing with system-level, 21 CFR Part 11 and EU Annex 11-compliant audit trails and electronic signature boxes, and results in reduced cycle times, consistent first-pass readiness, streamlined global registration monitoring, and higher state of inspection-readiness. The conclusion advocates adopting a regime-specific, purpose-built RIM platform and suggests exploring AI-assisted planning along with agentic workflows, without losing human judgment or validated system requirements.

PAGES: 104-111  |  13 VIEWS  7 DOWNLOADS