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Streamlining Audit Management and Planning for a Biotech Company

Clarkston partnered with the Quality Assurance function at a top revenue-generating RNAi therapeutics company to bring efficiency to the good manufacturing practice (GMP)/good distribution practice (GDP) audit dashboarding, planning and resource allocation processes through a Smartsheet implementation. The client wanted to alleviate the nuances of the previously manual and time-consuming data-pulling process that dedicated over eight hours a week to transposing siloed reports into a static, easily corrupted Excel spreadsheet. Using Smartsheet, Clarkston provided the client with a dynamic, innovative solution that will continue to add value to the organization and improve the overall audit management and planning activities for resource management. 

Download the Audit Management and Planning Case Study Here

After transferring the current pipeline of 100+ upcoming audits from Veeva to Smartsheet, requirement-gathering sessions and refinement sessions were held with key stakeholders to identify key performance indicators (KPIs) that would alleviate the previously manual audit tracking framework. Automatic workflows and controls have been put in place to increase the percentage of on-time audit closures. Additionally, department-specific, regional, and role-based views were created to increase the visibility of auditing activities among auditors and across the organization.  

The client’s goal through this implementation was to centralize audit schedules and tasks for tracking needs and create an audit plan in Smartsheet that would support the proactive scheduling and coordination of audit activities. As a result of Clarkston’s expertise, the client continues to experience ease with audit planning, on-time audit closure tracking, alignment of auditors, and increased visibility into audit activities across the organization.

Download the Audit Management and Planning case study here. Learn more about our Project Management Consulting services by contacting us below. 

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Tags: Case Study, Project & Program Management