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PSMF Tool Implementation Guidance

Digitizing your Pharmacovigilance System Master File (PSMF) in any GxP platform is not a plug-and-play exercise. If you skip role clarity and validation planning, your migration will stall or fail inspection.

Get the PSMF Tool Implementation Checklist in the PDF below

What You’ll Learn in the Checklist

  • The 8-point readiness self-check (don’t skip this)
  • What “owning configuration” actually requires
  • Timeline benchmarks for URS → PQ stack
  • Governance items too often skipped (until go-live fails)

Who This Is For

  • Biotech or mid-sized pharma scaling safety ops pre-MAA
  • Teams migrating off SharePoint, PleaseReview, Excel
  • PV leaders building internal QPPV/PSMF capability

Who This Is Not For

  • Lift-and-shift buyers expecting plug-and-play setup
  • Teams with no role-based review discipline

Common Migration Pitfalls We Help Prevent

  • Cross-functional PSMF chaos: Everyone reviews everything.
  • Admin blind spots: No control over permissions or picklists.
  • Confused system-of-record ownership.
  • “Forgot to plan validation” syndrome.
  • Training, SOPs, and integrations treated as afterthoughts.

Want to Talk It Through?

Reach out to schedule a consultation about following topics:

  • Sketching your routing map (e.g., contributor only reviews Annex D01)
  • Defining your metadata, permissions, admin model
  • Estimating realistic validation durations: URS, FS, FRA, IQ, OQ, PQ
  • Identification of quick wins to simplify your workflow or mirror it cleanly
  • Or any other topics relevant to your current situation

Reach Out to Book a Consultation