Compliance Audits Built For Regulatory Changes

Our compliance audits are completed with timeliness and ease.

Best practices dictate that FDA regulated medical device and pharmaceutical manufacturers complete regular, internal audits. These audits must review each element of the Quality Management System to assure there are no system gaps or operational problems. If gaps or problems are identified, a Corrective and Preventative action plan must be documented, executed, checked for effectiveness, and reviewed with management. This quality directive typically pulls employee resources away from profit-generating projects and normal job duties.

One of the largest strains on the staff occurs near the end of the year, when the manufacturing and quality team is required to put aside time to audit quality subsections. This causes internal work stress and business interruption since audit findings must be corrected and documented; Each CAPA generated from this process may take additional time from operations, requiring timeframes as long as 10 weeks, or even longer, to resolve.

How Compliance Team can help:

Our experienced Compliance experts will review all quality subsystems over the course of a year. Each month, our third-party auditors will assess a rotating quality subsystem, identify gaps, initiate CAPAs and assist with the remediation efforts. At the end of 12 months your entire quality system will be fully audited, simplifying your year-end work activities, and easing the workload for the following year.

We’re ready to assist with your FDA mock inspections, MDSAP preparation audits, and ISO-13485 preparation audits.

  • We help you review your QMS in a shorter amount of time.
  • Your CAPAs are documented earlier in the year, leaving more time to remediate.
  • Your QMS is reviewed all year long, ensuring issues are identified more quickly.
  • We provide 3rd party objectivity of your internal quality operations.