Business Problem

The client was in the late stages of clinical testing and was preparing for approval and commercialization. This required significant remediation of current systems and validation/compliance support for the systems to meet organizational processes requirements and inspection readiness. Also the company was expanding and there was a large number of major technology projects in the pipeline. The organization needed be prepared to absorb and adopt all of this change and improve their compliance profile.

Hawkins Point Solution

Hawkins Point Partners leveraged our IT Quality Framework and accelerators as well as Organizational Change Management playbook to create a pragmatic remediation roadmap and ongoing organizational culture change. We leveraged our knowledge base, validation governance toolkit and industry best practices. We delivered a quality system, executed a remediation strategy, and implemented a repeatable quality process. We supported the correction of numerous system compliance gaps and managed implementation and validation of other systems.

Results

  • Repeatable CapabilityFor quality and validation management capability, with all methods, standards, tools, and templates, and with embedded continuous improvement
  • Fully Prepared OrganizationIncluding impacted team members and business customers
  • Rightsized ImplementationOf quality framework and remediation of systems to optimize value and minimize future administrative burden