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FDA GMP Quality System Audits

When Your System Stalls, You Can’t Afford to Stall.

After you are audited, problematic issues that have built up are much harder to stop and correct. Plus, once the FDA gets involved, you lose control over how to fix those issues. How can you ensure continuous improvement instead of consistent delays? By putting an ongoing quality system audit process in place.

Things can get extremely complicated and chaotic when regulatory and compliance documentation is overlooked or incorrectly recorded. As Good Manufacturing Practices (GMP) Consultants, Medical Engineering Consultants provides the internal auditing services medical device manufacturers in North America, Europe and Japan require to measure the effectiveness of their quality systems. These systems are designed to identify problems to fix before the FDA comes into the picture. Here’s what else they do:

Gap Analysis Audits: Where are the Gaps in Your Process?

An MEC GMP Gap Analysis Audit pinpoints areas of deficiency and helps you counter them by putting adequate controls in place – all while keeping your devices FDA, ISO 13485, Japan PAL Z or CMDR compliant.

Pre-Assessment Audits: Stop Problems Before They Become Problems

What do you need to know when your company has an upcoming Certification Audit? Wouldn’t you prefer to know in what areas you are non-compliant and correct them ahead of time? Your company can achieve these goals with a Pre-Assessment Audit conducted by an MEC GMP Consultant.

Full or Partial Internal Audits: Assess Entire Systems or Specific Areas

An independent, internal quality system assessment audit that meets ISO and FDA QSR standards allows you to produce devices that consistently meet regulatory requirements. MEC GMP consultants are trained to handle mandatory FDA internal quality system audits, partial or specific areas of non-compliance audits, subcontractor audits and supplier audits.

To make sure all of your company’s processes and products conform with FDA, iSO and QS specifications, contact Medical Engineering Consultants.

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