Regulatory Adherence

Solutions that ensure compliance with regulatory requirements

Plasma collections are highly regulated, and an FDA investigation can shut down processing and severely damage a business’s profitability and future.
ACCESS1 Health helps plasma companies effectively manage their quality process to ensure regulatory requirements are fulfilled and maintained. The custom systems created by ACCESS1 are based upon industry best practices and deep knowledge of applicable regulations. These systems can be easily and cost-effectively tailored to meet specific company needs and workflows.
ACCESS1 systems monitor and track processes, then report the problem or deviation. Users are notified so they can take corrective steps as well as preventative actions, which are entered into the software system. The software then produces documentation needed for compliance purposes. Modules within the system include:
  • CAPA management (Corrective Action Preventative Action)
  • Tracking management
  • Stability management
  • Standards management

Contact us to learn more about this and other custom plasma solutions from ACCESS1 Health.