Shared-responsibility oversight, supplier assurance, release and change assessment, periodic review, and evidence you can retrieve quickly and defend under inspection scrutiny.
SaaS governance gaps are among the most common findings in regulated environments. The platform is deployed, but the governance framework around it is either absent or untested under scrutiny.
Intended use, shared responsibilities and what evidence you rely on the supplier to provide, explicit, documented and retrievable.
Documented rationale, risk linkage and consistent evidence points for every supplier release, not "noted and filed".
Periodic review aligned to risk and operational performance, including incidents, deviations, access recertification and trends.
An operational control model with clear ownership, escalation paths and evidence that controls operate, not just that they exist.
Based on a genuine engagement. Details are anonymised, and in some cases composited, to protect client confidentiality.
A pharmaceutical company had expanded its use of cloud-based SaaS platforms including a validated eQMS and a supplier management tool, but had no defined governance model in place. Individual system owners were managing changes in isolation, and vendor notifications were not being captured, reviewed or risk-assessed as a matter of routine.
Periodic review had not been completed on any cloud-hosted GxP system since initial validation. Shared responsibility between the organisation and its SaaS vendors had never been formally documented. A regulatory inspection would have found no structured oversight of how these systems were being maintained in a validated state.
A SaaS governance framework was designed and implemented covering supplier qualification criteria, change notification management, shared responsibility matrices, configuration baseline records and a structured periodic review process. The framework was deployed across all in-scope cloud GxP systems and embedded into the site's quality management calendar.
All cloud GxP systems were brought into a documented, repeatable governance cycle within one quarter. A subsequent regulatory audit found no observations relating to computerised system management or vendor oversight.
Book a call to discuss your platforms, your supplier landscape and what a defensible governance pack needs to cover.