Clarkston recently partnered with a biopharmaceutical company on their FDA inspection readiness for business systems project. This company develops, manufactures, and markets regenerative biologics for multiple sectors of healthcare.
The organization was questioning the “audit ready” status of their business systems in advance of a new product launch. The company determined they needed to take action so they requested Clarkston’s help with an assessment of their validation documentation for their business systems and associated infrastructure which was housed at their third-party data center provider .
The primary objectives for this project included performing an assessment and retrospective Installation Qualification for the business systems and associated infrastructure at the third-party data center provider, perform assessments, and create an “audit ready” packet of computer system validation documentation to ensure compliance with industry.
Clarkston Consulting collaborated with the client to perform an assessment of their validation documentation and retrospective qualification of the business systems and associated infrastructure housed with their third-party data center provider. The client wanted to create an “audit ready” packet of validation documentation to ensure compliance with industry standards. The benefits of this approach provided the client with defensible documentation of computer system validation, traceability back to vendor settings, ability to troubleshoot, ability to regression test, and ability to upgrade.
The resolution of this project enabled the review of the Hosting agreement, Data Center Hosting provider documentation, recommendations for the business, and identified gaps among supported documentation. The key benefits from this project resulted in defensible documentation of FDA Computer System Validation for critical business systems, traceability, and the ability to troubleshoot, perform upgrades, and regression testing providing FDA inspection readiness for their business systems.