This week our team hosted an insightful webinar on exceptions management and rework featuring an exciting guest, Rick Seibert – CIO and Senior Vice President of Corporate Technical Services at Sharp.  

The session delved into the perspective of solution providers and CMOs regarding the stabilization period and exceptions handling. Rick articulated the need to be flexible as a contract service provider, to meet customer expectations across the diverse spectrum of clients. From those well-versed in regulation requirements with established systems in place, to those still navigating the regulatory landscape.  

As we transitioned into the exceptions management segment of the webinar, the group acknowledged a significant uptick in exceptions over the past few months, attributable to the increased flow and exchange of data. Efficiency in handling these exceptions improves with exposure, prompting a call for proactive adaptation. Sharp actively collaborates with partners like Systech to navigate emerging scenarios as they arise, fostering agility and resilience. 

Some of the more common scenarios for rework or reprocessing that Rick has observed include:  

• Sample pulling  
• Complaint investigations  
• Product damaged in transit  

Trading partners must ensure that their business processes are adaptable enough to accommodate various scenarios, including unforeseen ones. In the volatile pharmaceutical landscape, it is imperative to “show your work.” Simply altering data is insufficient; there must be a transparent audit trail documenting the actions taken.  

Additionally, there are instances where there is a pressing need to swiftly address exceptions and ensure the uninterrupted flow of products, particularly in cases involving cold chain or frozen products. Given the critical time sensitivity associated with maintaining the quality of such products, Rick emphasized the necessity for even more rapid response times. 

When it comes to collaborating with trading partners during the remaining stabilization period, Rick stressed the importance of establishing internal standards that meet the minimum market requirements and align with industry best practices, while maintaining a flexible and evolving approach. Rick also highlighted the value of partnering with top-tier vendors like Systech to leverage cutting-edge technology. 

To know more, get access to the on-demand recording of the webinar available for download.