Audit
Service Detail

Audit Services

Independent GxP audit support across manufacturing, laboratories, suppliers, and digital vendors to identify compliance risks, strengthen inspection readiness, and guide practical remediation.

Scope
Overview

What this service covers.

This service is designed for regulated manufacturers, laboratories, and life sciences organisations that need structured audit support before inspections, supplier approval, remediation planning, or quality programme improvement.

Audit support areas

  • GMP, GLP, and GCP audit support across API, formulation, injectable, R&D, and bioequivalence environments.
  • Supplier and third-party audits, including vendor qualification and ongoing audit programmes.
  • Remote IT vendor audits for digital and regulated technology providers.
  • Gap assessments, data integrity reviews, and mock inspection preparation.

Typical deliverables

  • Audit plans, checklists, and structured observation reports.
  • Risk-ranked findings and CAPA follow-up recommendations.
  • Management-ready summaries for remediation prioritisation.
  • Inspection readiness support aligned to current quality and regulatory expectations.
Approach
Approach

How we typically deliver audit engagements.

Step 01

Scope Definition

We define the site, system, supplier, or process scope and align the audit against applicable regulations and business objectives.

Step 02

Audit Execution

We perform the review onsite or remotely, assess evidence, interview stakeholders, and document observations clearly.

Step 03

Gap Reporting

Findings are prioritised so teams understand critical, major, and improvement-level actions.

Step 04

Remediation Planning

We help translate audit findings into CAPA, validation, policy, or governance next steps.

Contact

Get in touch.

Tell us about your environment, current gaps, or systems in scope. We will review the details and come back with the most suitable next step.

Geographical Locations
USAIrelandItalyIndia
Audit ServicesSupplier, GMP, GLP, GCP, and vendor audits
CSV / CSAValidation, remediation, and inspection support
AI SolutionsAgents, bots, workflow automation, and on-prem AI
Geographical LocationsUSA, Ireland, Italy, India