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Case study

SAP serialization for a pharma manufacturer

Scope
  • SAP ATTP
  • GxP Validation
  • SOW Delivery
  1. Scope
  2. Team
  3. Delivery

Result

Serialization went live ahead of the compliance deadline, with a validated system and a trained internal team to run it.

Challenge

A pharmaceutical manufacturer faced regulatory deadlines for track-and-trace serialization across global markets, with no in-house SAP ATTP expertise.

Global track-and-trace mandates — DSCSA in the US, FMD in Europe and parallel regimes across emerging markets — turned serialization from a nice-to-have into a license-to-sell requirement for pharmaceutical manufacturers. Our client, a growing manufacturer with export commitments in multiple regulated markets, faced staggered compliance deadlines with no in-house SAP ATTP capability and a hiring market where that skill commands months of lead time.

Approach

MyTech Global deployed a specialist SAP team on an SOW basis — solution design, configuration and validation documentation aligned to GxP requirements.

Validation ran in parallel with build rather than as a terminal phase, which is where most serialization programs lose their deadlines.
From the case study

Buying the skill permanently made no sense for a bounded program; renting unaccountable freelancers made even less. The engagement was structured as a fixed-scope SOW: solution design, system configuration, integration with packaging lines, and the validation documentation a GxP environment demands — protocols, executed test evidence and traceability matrices a regulator can walk through.

The MyTech Global team ran design workshops with quality and packaging stakeholders, configured SAP ATTP across the required market profiles, and integrated serial-number management with line-level equipment. Validation ran in parallel with build rather than as a terminal phase, which is where most serialization programs lose their deadlines.

Result

Serialization went live ahead of the first compliance deadline. The client's internal team was trained through hypercare and took over steady-state operations with documented runbooks — no permanent dependency on us, which was the point.

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