AUDIT 4 LIFE™

Your Outsourced Audit Partner for GMP & ISO 13485

Stop chasing audits - Start managing risk!

  • Internal audits get delayed — and every month they slip, undetected nonconformances keep piling up, quietly waiting for an inspector to find them first.

  • Supplier audits get pushed back — so you're trusting critical suppliers on blind faith, with no evidence to back you up when something goes wrong.

  • New vendors get approved without sufficient due diligence — meaning you could be building your supply chain on a foundation you haven't actually verified.

  • Inspection dates arrive faster than expected — and suddenly you're scrambling to explain gaps you didn't even know existed, in front of the one audience that doesn't accept "we were getting to it."

  • Your audit schedule sits in a spreadsheet nobody's opened in months — which means nobody in your organization can actually tell you, right now, where your compliance risk is hiding.

When regulators inspect your business, they don't simply ask whether you've completed your audits — they want evidence that you have a planned, risk-based audit programme that guarantees your product safety and quality, and that you've followed it.

Audit4Life™ helps you stay on track

Whether you need a single audit or an experienced partner to manage your entire audit programme, Quality Systems Now provides independent, regulator-focused audits that strengthen your regulatory compliance and keep your organisation inspection ready

What We Do

Every organisation has different risks, suppliers and regulatory obligations.

That's why we work with your audit programme, your supplier qualification process and your business priorities.

We become an extension of your Quality team, delivering audits when they're due and providing experienced auditors whenever you need them.

Internal Audits

Meet your internal audit obligations while gaining genuine insight into your QMS, processes and systems.

We conduct independent internal audits against your own procedures and applicable regulatory requirements to identify compliance gaps, systemic risks and opportunities for continual improvement.

  • Annual or quarterly internal audit programmes

  • Process audits

  • Department audits

  • Quality Management System audits

  • Follow-up verification audits

Mock Regulatory Inspections

Experience the inspection before it happens. Don't wait for the regulator to identify your weaknesses.

We simulate inspections using the same approach regulators use, helping your team prepare before agencies arrive:

  • Therapeutic Goods Administration (TGA)

  • U.S. Food and Drug Administration

  • European Medicines Agency and EU GMP inspectorates

  • ISO certification and accreditation bodies

Third-Party & Supplier Audits

Your suppliers are an extension of your company.

Whether you're qualifying a new supplier or maintaining oversight of an existing one, we provide objective assessments that support your supplier qualification programme.

  • Contract manufacturers

  • API suppliers

  • Raw material suppliers

  • Packaging suppliers

  • Testing laboratories

  • Critical service providers

Flexible Delivery

Whether your site is across town or across the world, we can tailor the audit to suit your timeline and budget.

We offer:

  • On-site Audits - full facility, QMS, systems and processes

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

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

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

This flexibility allows organisations to obtain timely, independent audit support without unnecessary travel delays.

Audit 4 Life™ - Your Managed Audit Programme

Many organisations have an audit schedule. Far fewer consistently deliver it.

Audit4Life™ is designed for organisations that want an experienced audit partner to help manage and deliver their ongoing audit programme.

Working from your approved audit schedule, we coordinate with you and perform audits as they become due, ensuring your audit commitments don't fall behind.

This might include:

  • Internal audits scheduled quarterly or annually

  • Manufacturing site audits every two years

  • Critical, high-risk supplier audits every year

  • New supplier qualification audits

  • Follow-up or for-cause audits after significant quality events

  • Additional audits following major changes or identified risks.

You remain in control of your audit programme. We help you execute it.

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

Why Organisations Choose Audit4Life™

  • Independent, qualified auditors with extensive GMP and medical device experience

  • Flexible on-site, desktop and hybrid inspection

  • Internal, supplier and mock regulatory inspections

  • One-off audits or fully managed audit programmes

  • Risk-based auditing focused on regulatory expectations

  • Clear, practical reports with actionable recommendations

Ready to Strengthen Your Audit Programme?

Whether you need a single audit, assistance qualifying a new supplier, or an experienced partner to manage your ongoing audit programme, we're here to help.