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FDA Regulatory and Compliance

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  • FDA Regulatory and Compliance

FDA regulatory and compliance services to meet FDA regulations: Software Validation, Infrastructure Qualification, and Supplier Audits.

Shoolin 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 Shoolin’s services used to meet FDA regulations include software validation, infrastructure qualification, and supplier audits.

Shoolin'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, Shoolin 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 your business risk quickly and reliably.

Our Track Record with FDA Compliance and Validation

  • 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

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