Deviation Management Addresses Key Compliance and Production Issues for Global Client
After dealing with ongoing compliance issues, our global pharmaceutical client retained the services of Sciras to provide strong leadership and project management support in managing and improving their deviation management quality system.
INDUSTRY
Pharmaceuticals
AREA OF EXPERTISE
Regulatory Compliance
DURATION
12 Months
SERVICES PROVIDED
- Project Management
- Deviation Management
- Business Process Improvement
IMPACT
Within one year and with the support of Sciras’ services, the overall number of deviations was successfully reduced by the targeted 25%.
Business Challenge
Our client is a leading global pharmaceutical company that was encountering ongoing compliance issues that affected their deviation management system. Sciras consultants were brought in to provide project management support in managing and improving their deviation management quality system.
Our Approach
The consultants assisted the client in undergoing a review of their existing processes and implementing a successful improvement strategy. Next, they provided a well-defined scope to reduce the total number of deviations and prioritized deviation completion through criteria established by upper management. Throughout the process, the consultants facilitated meetings and working sessions with internal and external stakeholders, to aid in deviation closure.
Due to the large scope of the project, the deviations were prioritized and tracked regularly through performance metrics and communication tools.
Results Achieved
- Reduced the overall number of deviations by the targeted 25% within one year
- Increased the deviation closure rate
- Achieved a 0% overdue deviations rate in three consecutive months
- Systematically organized and tracked the status of approximately 300 deviations
- Supported the logistics of deviation closure through effective project management
- Developed an approach for addressing communication gaps using SharePoint
