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Provision’s quality system team will work within your organization to create and develop your processes. Our deep knowledge in Quality Management System Compliance and Process Improvement helps companies improve features, reduce costs, and increase quality – all done within compliance to keep the FDA satisfied and focused one someone other than you.

Provision’s experience and understanding of the FDA allows us to successfully develop appropriate responses to compliance issues and implement comprehensive strategies that help move the client forward. Clients count on our ability to build strong relationships with their management teams while meeting their goals, and to leverage our successful experiences in dealing with the FDA. 

US FDA 21 CFR (Code of Federal Regulation) part 820, 210 and 211 demands a structured system to make sure that the quality of a product remains faithful to its indications for us, consistent, and safe. There are ISO 9001, ISO 22716, and ISO 13485, but may not be enough to meet the requirements by the FDA. Moreover, a product's unique characteristics may need to be addressed in a manner that will be acceptable to the FDA. For example, software utilization is one of the areas in which much of the industry's attention has been shifting, and therefore, you will need to consider how its implementation and its impact will affect your quality system. Building such a system requires strong cooperation with our consultants, and we can get into your team and create a system that fits for your company.

Provision FDA Quality Management System Consulting Services:
  • Mock-up Audit (on-site or online) for CFR 820, CFR 210, CFR 211

  • Draft SOP

  • SOP Implementation

  • Training

  • Management

  • Representative Role Upon Audit

  • Personnel Qualification and Staffing

  • Investigations

  • CAPA

  • Document Management

  • Electronic Quality Management Systems

  • Process Validation

  • Cleaning Validation

  • Equipment Qualification and Validation

  • Manufacturing Batch Records

  • Packaging Batch Records

  • Part 11 Compliance

  • Laboratory Controls

  • Analytical Method Validation

  • Supplier Qualification Program

  • Internal Audit Program

  • Raw Material Testing and Controls

  • Environmental Monitoring

  • Inventory Management

  • 483 Obsevations

  • Warning Letter Response

  • Recalls and Corrections

  • Regulatory Liaison During FDA Audit

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