Available on

Apple Android Windows

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

Want to learn more about GoCanvas?

Request a Demo

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

Included Features

Our App Builder gives you the power to easily add and remove the ones you want. {{controller.show_all ? 'See included features.' : 'See more features.'}}

  • {{data.title}}

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!

Related Government & NGO Apps... and they're all free for GoCanvas subscribers!

App Name

USDA Physical Security Checklist: Com...

The USDA Physical Security Checklist: Communications mobile app is an element of the USDA Physical Security Program. It is...

App Name

USDA Physical Security Checklist: Lan...

The USDA Physical Security Checklist: Landscaping mobile app is a section of the USDA Physical Security Program. It is dev...

App Name

USDA: Prevent Foodborne Illness

Most foodborne illnesses are caused by harmful microorganisms—tiny, living organisms that are so small they can be seen on...

App Name

USDA GAP Audit Checklist: Water Usage

The USDA GAP Audit Checklist: Water Usage mobile app is a part of the USDA Good Agricultural Practices & Good Handling...

App Name

Good Agricultural Practices (GAP): St...

The Good Agricultural Practices (GAP): Storage Pest Management Program mobile app was built to keep up your farming operat...

App Name

USDA Pre-Harvest Security Guidelines:...

In recent years there has been an increased awareness of the vulnerability to food and agricultural, to acts of terrorism....

App Name

School Food Defense Plan

Food defense is having measures in place to reduce the chances of someone intentionally contaminating the food used in you...

App Name

USDA GAP Audit Checklist :Preventive ...

The USDA GAP Audit Checklist: Preventive Food Defense Procedures mobile app was designed to assess efforts to minimize t...

More Information

Related Blog Posts