On The Frontline
The countdown is in full swing for drug manufacturers to meet the 11-27-2017 milestone of the US Drug Supply Chain Security Act. Unfortunately, time is not on the side of companies who are still planning how to transition from lot-level traceability to item-level serialization of drug product.
Are you involved in the delivery of a serialization solution? By now, you have read a plethora of white papers and essays, attended conferences, and understand item-level serialization is exponentially more complex than lot-level tracking. You are confident you understand areas of risk. You think you understand your organization. But are you asking the right questions internally to remove potential barriers to success?
An integration project of this magnitude in a heavily regulated industry is an inherently complex and costly undertaking -- when factoring in software and hardware validation, document control, change management, quality and compliance, new technologies, to name a few. Lurking “in the weeds” are additional factors, which if not proactively managed, can rapidly involve into costly issues.
On the Frontline has identified 5 additional factors which should not be overlooked:
Over the course of the next 5 weeks, On the Frontline will delve into each of these factors in greater detail. Assessments and evaluations will determine if remediation is needed.
Avoid costly mistakes by proactively fleshing-out potential barriers to success. It is never too late to start!
Dean Crockett is a Senior Consultant with ValidDatum, a GS1 solution provider offering data-centric consulting solutions for the Life Sciences industry. Dean has been involved in many Supply Chain and Manufacturing integration projects over the course of 18 years in the Life Science industry, 6 years of which have been focused on serialization. As primarily an individual contributor on serialization programs, Dean translates the unique perspective of an experienced Integration Specialist, Project Lead, Technical Architect, and Business Analyst into valuable lessons learned. On The Frontline is written from this unique perspective. http://www.validdatum.com/
The countdown is in full swing for drug manufacturers to meet the 11-27-2017 milestone of the US Drug Supply Chain Security Act. Unfortunately, time is not on the side of companies who are still planning how to transition from lot-level traceability to item-level serialization of drug product.
Are you involved in the delivery of a serialization solution? By now, you have read a plethora of white papers and essays, attended conferences, and understand item-level serialization is exponentially more complex than lot-level tracking. You are confident you understand areas of risk. You think you understand your organization. But are you asking the right questions internally to remove potential barriers to success?
An integration project of this magnitude in a heavily regulated industry is an inherently complex and costly undertaking -- when factoring in software and hardware validation, document control, change management, quality and compliance, new technologies, to name a few. Lurking “in the weeds” are additional factors, which if not proactively managed, can rapidly involve into costly issues.
On the Frontline has identified 5 additional factors which should not be overlooked:
- DSCSA scope is internalized and understood within all Quality groups
- Ensure understanding of relationship with CMO/3PL Trading Partners
- PMO Portfolio Manager intimate with all Distribution projects
- A Core Business driven serialization program
- Is a new Change Management paradigm needed
Over the course of the next 5 weeks, On the Frontline will delve into each of these factors in greater detail. Assessments and evaluations will determine if remediation is needed.
Avoid costly mistakes by proactively fleshing-out potential barriers to success. It is never too late to start!
Dean Crockett is a Senior Consultant with ValidDatum, a GS1 solution provider offering data-centric consulting solutions for the Life Sciences industry. Dean has been involved in many Supply Chain and Manufacturing integration projects over the course of 18 years in the Life Science industry, 6 years of which have been focused on serialization. As primarily an individual contributor on serialization programs, Dean translates the unique perspective of an experienced Integration Specialist, Project Lead, Technical Architect, and Business Analyst into valuable lessons learned. On The Frontline is written from this unique perspective. http://www.validdatum.com/