As organizations plan their serialization initiative, I often find that the effort required to validate the complete solution is underestimated.  Serialization requires equipment, process and computer system validation, and the timelines and approach for each of these is different. Validating the corporate level system (level 4) follows the typical computer system validation approach – something most organizations are somewhat familiar with estimating. However, the validation required at the packaging line (levels 1, 2 and 3) follows a different approach and timeline.  The use cases that need to be tested and validated at the line-level are most often significant, and this where the validation efforts are well under-estimated.

When developing your estimates for validation, I would offer three suggestions:

1. Develop your validation estimates based on the validation requirements at the packaging line.
2. Pilot a single line to establish a benchmark for the validation effort.  Read more about creating a pilot in this case study on Piloting Serialization.
3. Engage your quality assurance and validation resources at the start of the project to ensure all validation activities are integrated into your overall work plan.

Remember, validation is the longest pole in the tent.  Effectively planning your validation effort upfront will ensure that the various project streams are working in concert and help you avoid re-validating components of the solution.