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FDA: Change Control Audit Checklist Mobile App

The FDA Change Control Audit mobile app covers the basic elements that must be completed as part of a change control program. Easily accessible from any smartphone or tablet, the app generates a checklist of guidelines to follow and creates electronic records of the completed items to ensure FDA compliance. Designed for medical device manufacturers and other types of items that require FDA inspections, the FDA Change Control app makes it easy to develop a change management control plan that meets the regulatory requirements of FDA inspectors and internal auditors.

While having a change control plan in place isn't necessarily required during the initial research and development phases of a new medical device or product, it is required (as part of FDA regulations) before the equipment is deemed ""ready for production"". Having a change management plan in place early in the process helps ensure FDA regulatory compliance. The app covers the most important aspects of developing quality systems and change control for clinical trials, risk management and design control.

  • Lendlease
  • The Cooperative
  • PG&E
  • Red Bull
  • Mirvac

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Take a peek inside the FDA: Change Control Audit Checklist Mobile App

Included Features

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Included Fields

Customize to add, remove, or edit any of the fields below.

  • Ico checkbox

    Is there a written SOP covering the change control program that has been approved by the Quality...

  • Ico checkbox

    Does the SOP ensure that all changes are reviewed and approved by the Quality Unit?

  • Ico checkbox

    Do procedures require that the first lot manufactured after the change or date and time of imple...

  • Ico checkbox

    Is there a written requirement that changes implemented during normal or routine maintenance act...

  • Ico checkbox

    Does “change control” begin on or before approval of equipment qualification, product approval, ...

  • Ico checkbox

    If changes are classified as “major” or “minor,” do procedures clearly define the differences?

  • Ico checkbox

    Are assessment, implementation and verification requirements for each classification delineated ...

  • Ico checkbox

    Is there a process for canceling a change request prior to implementation?

  • Ico checkbox

    Does the change control program require that the movement of non-mobile equipment be documented ...

  • Ico statictext

    * If no, provide specific examples in the audit report

  • ...and More!

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