As preventative action from an assessment and remediation PMO, an industry leading pharmaceutical company needed to create a policy governing the use of sales tools. The policy needed to satisfy regulatory compliance requirements, but also be operationally feasible. Furthermore, the company required the ability to demonstrate adherence to policy via a quality oversight approach.
The Satori Solution
We facilitated the collaboration of many relevant departments related to sales, marketing, and regulatory compliance and others in the creation, revisions, and approval process through to senior leadership of two policies and supporting documents, ensuring consistency with the internal documentation approach and standards and consistency of terms with company-wide policy and SOP documentation. Working with operations, audit, and compliance departments, we facilitated creation of the tiered quality monitoring approach for assessing compliance to the policy, including defining KPIs and key supporting metrics, approach for sourcing the KPIs, reporting, and remediation actions.
We ensured that the policy was created and approved by senior leadership within the timeline specified in the CAPA, and the policy was subsequently implemented worldwide within the agreed-to timeline.