Pain is Weakness Leaving the Body!

I love this old military mantra!  Or then there’s “No pain no gain!”

Sometimes a little bit of pain goes a long way for ultimate success!

We accept this mantra at Quality Audit Consulting (QAC)!

We can help you get through your growing pains with a gap assessment for your Quality System.

Whether you are a new company, or one that has been around for a while and are branching out into new field of work or products.

We can help take the pain out of your Quality Management System (QMS).

We provide gap assessments, and document creation support to help you fill in the gaps of your QMS.

Gap Assessments are available against the following standards:

21 CFR 210 and 211 Current Good Manufacturing Practices for Finished Pharmaceuticals

21 CFR 820 Medical Devices – Quality Management System

ISO 9001:2015 Quality Management System

ISO 13485:2016 Medical Devices – Quality Management Systems

NIOSH 42 CFR 84 Respiratory Protective Devices

Gap Assessment Audits:

At QAC we complete gap assessment audits either online via virtual audit, or onsite audits.

We analyze the documents that currently make up your quality system and identify gaps and suggestions for your QMS improvement.

Records and specifications are reviewed to ensure that you are meeting regulatory requirements.

Documentation support is provided to create required documents or help you upgrade your current documents.

Contact us today!  matt@qualityauditconsulting.com

or visit our QMS website:  www.fdaqms.com

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