WHITE PAPER SERIES
In-depth frameworks, technical monographs and practical guidance on pharmacovigilance, responsible AI, and regulatory compliance.
Schilling Vigilance White Paper Series
The Schilling Vigilance White Paper Series provides independent analysis of pharmacovigilance governance, PSMF management, inspection readiness and the responsible use of artificial intelligence in regulated environments.
Each paper is authored by Reinhold Schilling and is available free of charge.
Showing 12 white papers
Schilling Vigilance
White Paper No. 1
White Paper No. 1
Rev. 0Five governance decisions that determine inspection readiness in the EU/EEA, the United Kingdom and Switzerland.
Schilling Vigilance
White Paper No. 2
White Paper No. 2
Rev. 0From Periodic Document Maintenance to a Controlled Digital Representation of the Pharmacovigilance System.
Schilling Vigilance
White Paper No. 3
White Paper No. 3
Rev. 0What start-ups really need to do.
Schilling Vigilance
White Paper No. 4
White Paper No. 4
Rev. 0Five decisions that determine inspection readiness across the EU, the United Kingdom and Switzerland.
Schilling Vigilance
White Paper No. 5
White Paper No. 5
Rev. 0From social-media message to controlled action using n8n and bounded AI.
Schilling Vigilance
White Paper No. 6
White Paper No. 6
Rev. 0Designing Effective Human Oversight in Pharmacovigilance AI
Schilling Vigilance
White Paper No. 7
White Paper No. 7
Rev. 0Maintaining the Validated State When AI Models Change in Pharmaceutical GxP Systems.
Schilling Vigilance
White Paper No. 8
White Paper No. 8
Rev. 0A Practical Due-Diligence and Oversight Framework.
Schilling Vigilance
White Paper No. 9
White Paper No. 9
Rev. 0Managing the Interfaces Between Pharmacovigilance, Product Complaints and Medical Information.
Schilling Vigilance
White Paper No. 10
White Paper No. 10
Rev. 0A Stage-Gated Implementation Model for Pharmacovigilance.
White Paper No. 11
White Paper No. 11 will not be published. It is provided exclusively to a conference beginning in 2027.
Schilling Vigilance
White Paper No. 12
White Paper No. 12
Version 1.0From Disproportionality Screening to Human-Governed, AI-Augmented Signal Management
Schilling Vigilance
White Paper No. 13
White Paper No. 13
Governance, lifecycle assurance and transaction-level traceability