Piramal Pharma + Leucine

Leucine's Solution Architecting team deployed on-ground across Piramal's facilities to conduct a comprehensive discovery exercise. The team physically walked production lines, sat with operators during shift handovers, and mapped every existing paper logbook, form, and data capture workflow — documenting not just the template formats, but how operators actually used them, what data fields were regulatory requirements versus local conventions, and where the gaps between sites existed.

Rather than digitising each site's existing formats, the team worked with Piramal's quality leadership and site operations heads to design something that hadn't existed before: a single, harmonised logbook standard for the entire global network. This standard had to satisfy a non-trivial constraint — it needed to work for every facility regardless of country or regulatory jurisdiction, while preserving the specific compliance requirements of the FDA (for US sites), the MHRA (for UK sites), and Indian regulatory authorities. The result was a unified set of logbook templates and data capture workflows that every facility could adopt without losing any site-specific regulatory obligations.

Each harmonised logbook was configured in the Leucine Production Logbook module within Leucine MES — with full 21 CFR Part 11 compliance built from the ground up. Electronic signatures with secure authentication, tamper-proof audit trails with automatic timestamping, role-based access controls, and process interlocks that enforce correct workflow sequencing so operators cannot skip or reorder steps. The system was configured to support ALCOA+ data integrity principles as a built-in requirement, not a bolted-on afterthought.

The rollout followed a phased site-by-site deployment model. Each facility went through its own cycle: on-ground training with operators and supervisors, configuration adjustments based on real shop-floor feedback, a parallel-run period where digital and paper systems operated side by side, and a formal cutover once the site's quality team validated the digital system. Later facilities benefited from the operational lessons of earlier ones.

The digitised logbooks were then connected to Piramal's existing enterprise systems — including SAP and their quality management workflows — through Leucine's open API and configurable connector architecture. Logbook data now flows directly into batch records, quality events, and reporting dashboards without manual re-entry. For the first time, Piramal's quality leadership has real-time visibility into shop-floor data capture across the entire global network from a single system.

Critically, this was as much a people challenge as a technology one. The Solution Architecting team ran hands-on training sessions at each facility, working directly with operators — many of whom had used paper logbooks for their entire careers. Training was conducted on the production floor using real workflows, not in classrooms with slide decks. The team worked with site management to demonstrate that the digital system reduced operator workload rather than adding to it, turning potential resistance into adoption.