Business Problem

As client grew closer to FDA approval they recognized the need for a robust Quality systems methodology and the governance documentation to meet organizational gaps and compliance with regulations. Client desired to take an iterative approach to identifying high priority SOPs, including change management, periodic review, and CSV procedures.

Hawkins Point Solution

Hawkins Point assessed the client’s plan and proposed additional necessary governance, which included a Quality Manual and CSV policy, validation deliverables, program governance and project management framework, assets and accelerators to build out the turn key quality systems, and execution work instructions to ensure successful validations and implementations. We developed all documentation and processes, and performed assessments based on the current industry standards. Hawkins Point focused on vendor management responsibilities for all software vendors and system integrators as contract gaps and opportunities to tighten vendor SLAs existed.

Results

  • Quality System ImplementationIncluding all validation deliverable templates
  • Framework for Contract SLAsVendor management services on behalf of the client reducing validation and systems administration burden
  • Pre-Inspection ReadinessFor IND submission