AUDIT 4 LIFE™

GMP & ISO 13485 Audit Services That Actually Prepare You for Inspection

Stop guessing if you’re compliant.

Know!

Whether you’re preparing for a licensing inspection, maintaining certification, or scaling your operations — your audit program determines how confident (or exposed) you really are.

At Quality Systems Now, we deliver regulator-aligned audits for pharmaceutical GMP and ISO 13485 companies — designed to identify real risks, not just tick boxes.

Are You Really Ready for Inspection?

Most companies think they are… until they’re not.

  • Your internal audits aren’t picking up critical gaps

  • Your team knows the process — but can they defend it under pressure?

  • Your documentation looks compliant — but is it actually controlled?

  • Your suppliers are approved — but are they truly qualified?

    Regulators don’t audit your intentions. They audit your evidence.

What We Do

We provide end-to-end audit services tailored to your stage, product, and regulatory pathway.

Internal Audits

Strengthen your systems before they are tested externally.

  • Full Quality Management System audits

  • Targeted process and system audits

  • Data integrity and documentation controls

  • Identification of systemic and recurring risks

Mock Regulatory Inspections

Experience the inspection before it happens.

  • Simulated regulatory audits

  • Interview-based assessments of your team

  • Real-time testing of systems, processes, and responses

  • Inspection-style reporting with clear findings

    Walk into your inspection knowing exactly what regulators will see.

Third-Party & Supplier Audits

Your compliance is only as strong as your supply chain.

  • Vendor qualification audits

  • Contract manufacturer and testing lab audits

  • Risk-based supplier evaluations

  • Ongoing supplier oversight

Flexible Delivery — When and Where You Need It

Audits don’t always fit neatly into timelines or travel plans. Inspections get scheduled. Investors apply pressure. Milestones shift. We adapt to your reality.

We offer:

  • On-site Audits - full facility and process assessment

  • Remote (desktop) Audits - rapid review of systems, documents, and records

  • Hybrid Audits - combining remote document review with targeted on-site verification

  • Rapid Deployment - short-notice audits when timelines are tight

Using secure tools like Zoom and structured document review, we can mobilise quickly without compromising audit depth.

  • Ideal for urgent inspection readiness

  • Access expertise regardless of location

  • Reduce delays and travel constraints

Outcome: You get the audit you need — when you need it.

Audit 4 Life™

Inspection readiness isn't a one-off activity - it's a system.

Audit 4 Life™ is our structured audit program designed to keep you continuously prepared:

  • Scheduled audits over time, aligned to your risk, preferred frequency and growth stage

  • Regular reassessment of critical systems

  • Visibility of trends and recurring issues to report into Management Review

  • Ideal for complimenting your internal or external audit programme

  • Ongoing alignment with regulatory expectations

  • Stay ready - not reactive

  • Build confidence across your team

  • Eliminate last-minute audit panic

Regulatory Coverage

Our audits are aligned to the regulatory frameworks relevant to your product and lifecycle stage.

Pharmaceutical GMP

  • Commercial pharmaceutical manufacturing (licensed facilities)

  • Complementary medicines

  • Blood and tissue products

  • Investigational / clinical-stage medicines

  • Due diligence and regulatory readiness assessments

Medical Devices

  • ISO 13485 Quality Management Systems

  • Software as a Medical Device (SaaS / SaMD)

  • In Vitro Diagnostics (IVDs)

  • Certification readiness and surveillance audits

Who This Is For

  • Companies preparing for GMP licensing or ISO 13485 certification

  • Organisations approaching a regulatory inspection

  • Teams scaling from clinical to commercial operations

  • Businesses needing independent, objective audit insight

  • Companies that want confidence in their systems, not assumptions

What You Get

  • Clear, structured audit reports (no vague observations)

  • Risk-based findings linked to regulatory expectations

  • Practical, actionable recommendations

  • Improved inspection readiness and team confidence

The Real Risk Isn't Failing an Audit

It's thinking you'll pass, and being wrong.

  • Delayed approvals or certifications

  • Repeat work and increased costs

  • Regulatory findings and scrutiny

  • Loss of confidence in your systems and data

    A strong audit program prevents this.

Ready to See What Regulators Will See?

Let’s assess where you are today — and what needs to change before your next audit or inspection.