BECS: Blood Establishment Computer System

The classification of a software program as a BECS (Blood Establishment Computer System) by the FDA obliges the implementation of an adequate model for its development and validation and which meets the demands of 21 CFR 606.

The breadth of experience available at CSV Experts in matters like these allows us to:

  • Prepare a Validation Plan that describes the validation tasks to be carried out.
  • Carry out a Risk Analysis of the system.
  • Collaborate with your develoment team to ensure that the risks posed by the system remain under control.
  • Prepare test procedures which demonstrate the correct system functionality respecting the functional design and regulatory requirements.
  • Create software quality system procedures.
  • Review the documentation related to the different components of the system.
  • Define a change control methodology and configuration management.
  • Define the records that would be required when faced with a regulatory inspection.
  • Prepare system documentation to support a 501 (k) submission.

See our corporative presentation