GXP Audits &
Performance Verification

Compliance is required. Predictable performance is essential.

We assess regulatory compliance and verify the statistical state of control of your processes before and during audit activity. This work strengthens audit outcomes, exposes hidden risk early, and ensures conclusions rest on objective evidence rather than narrative.

Our approach combines structured audit methodology with independent data analysis. It is delivered as part of a full GXP audit or as focused support to your internal or external auditors.

- Remove the blindfold -
Let the data support your audit and strengthen your judgement

What We Examine

Regulatory Compliance

  • GMP, GDP, GCP, GLP, PV systems and governance

  • Quality management system effectiveness and governance

  • Deviation, CAPA and change control processes

  • Supplier qualification and oversight

  • Data integrity controls

  • Inspection readiness and regulatory history

Operational Performance – What Sets Us Apart

  • Time ordered data for critical quality attributes and key process parameters

  • Process behavior charts for critical parameters

  • Process stability and capability relative to specifications

  • Trending of OOS, OOT and complaints

  • Water and microbiological control systems

  • Evidence that management distinguishes real (signals) issues from random (noise) issues

Audit Services

  • We assess manufacturers and suppliers across the full product lifecycle. Beyond GXP compliance, we evaluate batch history, deviation trends, process capability, and inspection history to identify operational and regulatory risk within your supply network.

  • Following recall, complaint, or regulatory finding, we conduct targeted analysis to determine whether the issue reflects isolated special cause or systemic instability. We evaluate root cause depth and whether proposed CAPA will restore control.

  • We support corporate audit programs by assessing compliance maturity and verifying evidence of sustained state of control across sites and functions. Our focus is governance, oversight effectiveness, and risk transparency.

  • We conduct an independent review of historical manufacturing and quality data to assess process predictability and regulatory risk. The output is structured, evidence based, and suitable for sharing directly with auditors or corporate oversight teams.

    Our review includes time ordered analysis of critical quality attributes, deviation and CAPA trends, stability performance, complaint signals, and inspection history. The objective is to provide a clear, data supported view of state of control when full audit support is not required.

Why Choose Verto Pharma?

Ex Regulatory Expertise
Our team includes former inspectors and QPs and senior GMP professionals with direct inspection and remediation experience.
We understand regulatory expectations, inspection risk, and enforcement triggers.

Bespoke Audit Teams
After defining scope, we assemble a focused team of subject matter experts in QA, manufacturing, QC, engineering, microbiology, or pharmacovigilance, aligned to your product, process, and lifecycle stage.

Compliance and Performance Insight
We assess GXP system compliance and examine operational data to verify state of control and process capability. We do not rely solely on documented procedures. We verify performance.

Clear, Risk Based Outcomes
You receive prioritized findings with practical actions linked to patient safety, regulatory exposure, and business risk.