Themes, gaps and practical controls.
Practical perspectives on evidence quality, governance and control effectiveness across regulated computerised systems, with emphasis on what regulators actually look for.
Twelve briefs on inspection-critical topics.
Each brief covers what regulators look for, where organisations commonly fall short, and what practical controls close the gap.
Translates ALCOA+ into a practical control model that can be implemented and evidenced across regulated systems, not just cited in SOPs.
Read brief →Audit trails only reduce risk when reviewed effectively. Covers what inspectors test and how to build a risk-based review model with practical evidence.
Read brief →Summarises how inspectors test electronic signature controls and what configuration, attribution and review evidence is expected.
Read brief →Explains what the CSA shift changes, and what it does not, so risk-based assurance decisions remain defensible under inspection.
Read brief →A pragmatic framework for supplier oversight that creates inspection-defensible evidence without creating disproportionate governance overhead.
Read brief →Describes a practical privileged access model that aligns security, validation and data integrity expectations into a single, auditable control structure.
Read brief →How to build proportionate restore testing evidence for GxP systems: what to test, how to document it, and what regulators look for.
Read brief →The governance controls needed to manage AI-enabled functionality in regulated environments without weakening traceability, control, or evidence quality.
Read brief →Applicability must be decided per system, recorded with rationale, and reviewed when the system changes. What a defensible determination looks like, and why undocumented assumptions fail under inspection.
Read brief →Internal review confirms documents exist. A mock inspection tests whether decisions can be explained under pressure. The gap between the two is where most PAI and MHRA observations originate.
Read brief →If these five questions are unclear before testing starts, the scope drifts, the documentation is weak, and the evidence package cannot be defended. The paperwork follows the questions.
Read brief →EU Annex 11 is explicit. Systems should be periodically evaluated to confirm they remain in a validated state. What a proportionate annual review covers and why validated systems silently drift without it.
Read brief →What surfaces most often under regulatory scrutiny.
Gaps in roles, ownership, review routines and evidence that controls operate consistently over time. ALCOA+ on paper; not in practice.
Configuration not aligned to intended use, weak review procedures, or unclear attribution: "who did what and why" cannot be demonstrated.
Insufficient ongoing monitoring, unclear responsibilities, and thin evidence of change impact assessment for vendor releases.
Evidence packs that exist, but do not clearly connect intended use, risk, testing depth and release rationale into a single coherent narrative.
SOPs present but not operationalised. Limited proof of adoption, training effectiveness and periodic review output.
Weak impact assessment, incomplete testing evidence, or inconsistent categorisation for regulated functionality across change events.
Three patterns we see repeatedly.
"We have documents," but limited evidence they operate
Reviewers look for proof of operation: review logs, exception handling, periodic checks and evidence that processes are repeatable. Link each procedure to objective evidence outputs: records, reports, tickets. Introduce lightweight operational evidence: sample-based checks, periodic access recertification.
Configured systems without a clear configuration baseline
For SaaS and configurable platforms, the validated state must be demonstrable: what settings exist today, how they are controlled and how changes are assessed. Maintain a configuration baseline and re-baseline after approved changes. Use risk-based testing aligned to intended use and regulated functions.
Supplier change information not connected to your impact assessment
Release notes alone are not enough. Your process must show assessment, decision and proportionate testing. Implement a simple supplier change triage with defined outcomes, responsibilities and a consistent evidence repository.
Want these themes mapped to your systems?
A focused readiness review translates these patterns into your environment, with prioritised gaps and a practical remediation plan.