Stringent regulations coupled with evolving product iterations leading to incomplete product design documentation (DHF) thus resulting in critical regulatory findings
Delays in regulatory approval in turn impacting customer’s partners' operations
Deficiency and gaps in DHF documentation leading to repeat design verification and validation activities that can cost time and effort and again delay regulatory approvals
Chaotic and unorganized DHF leading to difficulties in managing product changes and design traceability
Indegene established a dedicated centre of excellence (COE) of highly skilled quality professionals with expertise in medical device specific design controls and DHF management to perform a detailed gap analysis and execute the project
Indegene validated supplier inputs like drawings, reference data etc with a data-driven approach while working with a large number of customer's suppliers
Collaborative customer stakeholder coordination to complete documentation on time with subject matter experts to ensure alignment to the latest regulations and customer requirements
End-to-end program management with usage of templates, checklists, first-time right metrics, etc.