Security controls designed for regulated environments, focused on auditability, evidence quality and operational reality. Where systems are GxP-relevant, cybersecurity is part of the assurance model, not a separate silo.
The objective is not more security paperwork. The objective is demonstrable control operation aligned to risk, intended use and audit expectation.
Typical focus areas: access and privilege governance, logging and monitoring, vulnerability management, supplier assurance, and evidence that controls operate in BAU.
Based on a genuine engagement. Details are anonymised, and in some cases composited, to protect client confidentiality.
A biologics manufacturer preparing for a US FDA inspection identified that its GxP network architecture had never been formally reviewed against current cybersecurity expectations. Privileged access to multiple systems was undocumented, and backup and recovery processes had not been tested since the original system builds.
There was no privileged access management policy and no evidence of network segmentation verification between GxP and corporate infrastructure. Backup restore testing results did not exist in documented form. These gaps, if observed during an FDA inspection, would have constituted significant findings against data integrity and system control expectations.
A GxP cybersecurity review was directed in line with the ISPE GAMP Good Practice Guide and FDA data integrity expectations, engaging vetted specialist technical input for the network segmentation assessment. Deliverables included a gap register, network segmentation assessment, a formal privileged access policy, restructured user access records and documented backup restore test evidence covering all in-scope GxP systems.
All critical and high-priority findings were remediated before the inspection date. The FDA inspection team reviewed the cybersecurity and access management documentation and raised no observations relating to infrastructure controls, privileged access or backup and recovery.
Book a call to discuss your systems, your supplier landscape and what a proportionate control model needs to look like.