FDA QMS

Is a division of Quality Audit Consulting (QAC) and provides Quality System Consulting and Design support. We design Quality Management Systems for small to medium sized Pharmaceutical and Medical Device Companies.

Companies we work with include: Manufacturing companies for production of Hand Sanitizer, Face Masks, Active Pharmaceutical Ingredient Suppliers, Raw Material Suppliers, Drug Product Manufacturers, Contract Manufacturers, Warehouse and Distribution.

Examples of customized processes and procedures that we provide:

  • Quality Manuals

  • Document Control Procedure

  • Records Control Procedure

  • Change Control

  • Corrective and Preventive Action (CAPA) Procedure

  • Deviations Management Procedure

  • Nonconforming Material Procedure

  • Recall/Return Procedure

  • Complaints Procedure

  • Internal Audit Procedure

  • Personnel Qualifications Procedure (Training)

  • Master Validation Plan

Quality Management Systems (QMS)

The Quality Management Systems provided will be based upon FDA 21 CFR 210, 211, FDA Guidance Documents, EU Eudralex Vol. 4, ICH Q10, ICH Q11, 21 CFR 820, ISO 9001:2015, ISO 13485:2016, or 21 CFR 820 as appropriate for pharmaceutical or medical device related companies

FDA QMS provides packages for the type of company and size of company. After consultation with your company FDA QMS will provide you with a customized package designed to give you the essential processes and procedures you need to implement your Quality System and to be inspection ready for the FDA or other regulatory agency. Please visit our Quality Systems Packages page for further information.

Contact Us

phone: (707) 301-7411