Watch the ERP systems compliance and validation webinar!
Go to WebinarThe 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.
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:
Arbour Group provides packaged compliance solutions to companies in the life sciences industries 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. Some of Arbour Group’s services used to meet FDA regulations include software validation, infrastructure qualification, and supplier audits.
Arbour 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.
Whether dealing with FDA regulatory compliance requirements or other international regulations, Arbour 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.
Arbour Group delivers effective products and services that reduce the cost of compliance.
The Arbour Advantage delivers warranted solutions for managing compliance across the end-to-end supply chain at Life Sciences companies.
CFR Part 11 was established by the FDA in 1997 and clarified in 2007 and it applies to Electronic Record & Electronic Signatures and their related rules. CFR Part 11 establishes a requirement that computer systems used to create, modify and maintain electronic records & signatures are subject to validation. Computer systems (including hardware and software), controls and documentation must be readily available for and subject to FDA inspection and predicate rules apply, i.e., GMP, GCP, GLP.
Q: What are the Validation Deliverables?
A: The Validation Deliverables include:
Q: What needs to be validated?
A: Finished Pharmaceutical GMPs such as:
A: Medical Device GMPs such as:
Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.