The PSMF is meant to be a current description of a system. It became, in too many organizations, a static document that gets dusted off every now and then, at minimumwhen an inspection is announced.
That is not a regulatory failure. The EU pharmacovigilance legislation gives organizations latitude on how to maintain it. The failure is operational: PSMFs are written, signed, filed — and then the system they were meant to describe drifts.
I see similar patterns at the companies I work with. Annexes are out of date. The list of QPPV deputies in the document does not match the SOP. Contact data is not current. The data sources annex references a system that was retired twelve months ago. The summary of the pharmacovigilance system is a polished snapshot of a moment that already passed.
The fix is not more rigorous document control. The fix is to design the PSMF as the output of a flow — connected to the systems of record that actually change — rather than as a hand-maintained artefact.
This is what the upcoming pieces in this section will work through:
- Why the PSMF setup needs to be a push rather than a pull process and the implications of that for your operating model
- Where automation makes sense, and where regulators expect human judgement to remain visible
- How to map your existing PV system to a PSMF flow without re-engineering everything, but get rid of the abundant Excel trackers
- How to meet the regulatory requirements for the PSMF while also making it a useful tool for your team, rather than a compliance exercise
- The tools and integrations that make automatic PSMF maintenance auditable
The principle underneath all of it is the same one that runs through this publication: the regulation was always permissive enough. The constraint is the operating model.
More to follow.