Quality System Solutions

Achieving Sustainability in a Climate of Eliminated Corporate Resources

FDA Consultants will immediately supplement your organization to provide quality system solutions, which will comply with FDA and the appropriate International Regulatory Authorities regulations and standards.

Our Consultants can engineer and supply you with the appropriate FDA compliant documentation and training. Our Quality System solutions can be customized and implemented correctly into your organization for sustainability.

» Medical Devices/IVDs: FDA Consultants can prepare and implement the entire system or advise on a specific subsystem to meet the FDA QSR compliance (21 CFR 820: Quality System Regulation).

Our quality system program for medical device and IVD manufacturers focus on the proper implementation and sustainability of the following seven major subsystems:

1) Management Controls
2) Design Control
3) Corrective and Preventive Action (CAPA)
4) Production and Process Controls
5) Document Controls
6) Purchasing and Material Controls
7) Facility and Equipment Controls
*Medical Device Reporting- 21CFR Part 803

» Parmaceuticals/Biologics: Our approach to cGMP quality system implementation for biologic and pharmaceutical manufacturers (21 CFR Part 210 and 211) complies with FDA’s Compliance Program 7356.02.-A System Based Inspection of Drugs and focuses on the proper implementation and sustainability between the following six systems:

1 Quality Systems
2) Facility and Equipment Systems
3) Material Systems
4) Production Systems
5) Packaging and Labeling System
6) Laboratory Control System

We look forward to speaking with you about your specific project needs. Please use the Contact Us form so we can assign the right expertise for further discussion or call us at 800 782 0580 . Thank you.