FDA Complıance Consultancy

The Food and Drug Administration (FDA) is a US agency that ensures that food is safe and wholesome, that cosmetics will not harm humans and that medicines, medical devices and radiation-emitting consumer products are safe and effective. The FDA also protects the public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines and other biological products.

FDA regulatory compliance process includes reviewing regulated product, clearing products for sale, and maintaining post market surveillance.

Industrıes the FDA Regulates

According to the Food and Drug Administration, the FDA is the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices. It also regulates various other products, including food, cosmetics, veterinary drugs, radiation-emitting products, biological products and tobacco.

According to various FDA Warning Letters, here are some examples of common compliance mistakes:

  • “Failure to adequately validate according to established procedures.”
  • “Failure to review and approve design output before release.”
  • “Failed design validation that ensures the medical device conforms to defined user needs and intended users.”
  • “Failure to adequately establish procedures for acceptance of incoming product.”

Why Anatolıa Group for FDA Complıance and Valıdatıon

Anatolia Group provides packaged compliance solutions to companies looking to meet FDA regulations or other international regulations. We provide an alternative to manual labor-intensive validation efforts with a prepared compliance package incorporated with industry best practices.

Anatolia Group’s regulatory products include packaged validation protocols that help clients ensure that key ERP solutions are functional and in compliance with applicable regulations to minimize business risk. The process includes a validation plan template that scopes out the validation process, test script development that sets up the test objective, a business requirements model, and a traceability matrix. The package includes installation qualification test scripts, operation qualification test scripts, a performance qualification template, and a validation summary report template.

Our Track Record wıth FDA Complıance and Valıdatıon

  • Documented evidence that regulated functionality has been successfully tested for its intended uses
  • Procedures are in place to govern the use of the system and protection of data, i.e., SOPs/WIs, etc.
  • Training of users is evident in records
  • Change Control is maintained

Whether dealing with FDA regulatory compliance requirements or other international regulations, Anatolia Group can provide compliance solutions for medical device, pharmaceutical, and other life sciences regulation needs. Our expert services will assist in the proper preparation of FDA inspections and will manage you business risk quickly and reliably.

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