Pharmaceutical Online Details the Session: “Operational Excellence Through Connected Frontlines: A Case Study in Pharma Manufacturing, at the 2026 ISPE Europe Annual Conference”
18 May, 2026
At the 2026 ISPE Europe Annual Conference, Scott Slavens, IT Director, Eli Lilly and Company, along with Gilad Langer, Industry Practice Lead, Tulip, presented
a session, “Operational Excellence Through Connected Frontlines: A Case Study in Pharma Manufacturing.” During the session, the two outlined the technical, cultural, and regulatory considerations behind Lilly’s global rollout. In the article that follows, Slavens shares more about Lilly’s transition from paper logbooks to fully digital, integrated logbook systems, representing one of the company’s most significant operational modernization efforts. Slavens also describes how the organization designed a stepwise, frontline‑first digital transformation strategy that reduces compliance risk, improves data integrity, and accelerates manufacturing workflows.
Logbooks and batch records are among the most paper‑intensive and error‑prone elements of pharmaceutical manufacturing. Missing signatures, incomplete fields, and transcription errors create compliance vulnerabilities and slow down batch release. Digital logbooks eliminate many of these issues through built‑in completeness checks—users cannot proceed until required fields are filled—while enabling real‑time data capture and integration with other systems. Slavens notes that these “simple” digital features drive some of the most meaningful efficiency gains.
Lilly intentionally began the digitalization effort at the shop‑floor level. Instead of treating operators as end users, the company engaged them as subject matter experts during requirements definition, pilot testing, and iterative refinement. Sites that embraced this collaborative model transitioned faster and with fewer issues than those where the rollout felt top‑down.
Because digital systems require ongoing validation, Lilly embedded change control and validation competency into the program from the start. Every configuration change, software update, or new interface introduces potential risk, so the company built a governance model that ensures long‑term compliance without sacrificing agility.
The pilot phase focused on locking requirements for shared processes, developing applications with gap analysis across multiple sites, and validating the system through real‑world use on the shop floor. Once the pilot proved successful, Lilly expanded the rollout globally using a standardized but adaptable framework. The company’s approach emphasizes repeatable design, shared learnings, and cross‑site alignment—principles consistent with the broader digital‑transformation themes highlighted at the ISPE conference.
Digital logbooks sharply reduce completeness errors such as missing signatures or omitted fields. Transcription errors drop significantly when upstream systems are integrated, allowing data to flow automatically rather than being manually re‑entered.
The digital audit trail is more granular than paper ever allowed: every entry is timestamped, attributed to a specific user, and preserved as an immutable original record. Subsequent edits or annotations are additive, never overwriting the original. This aligns with US Food and Drug Administration expectations for 21 CFR Part 11 compliance and provides a more transparent, tamper‑evident record than paper.
One of the highest‑value outcomes is the real‑time equipment status model. For example, a cleaning deviation recorded in a digital logbook automatically flags the associated batch record and can place a hold on the next campaign. Reviewers can move seamlessly between equipment history and product records without reconstructing information from multiple systems. Slavens notes that paper will likely still be needed for regional regulatory requirements, but this interconnectedness that digital logbooks can help enable represents a major step toward predictive, data‑driven manufacturing.
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Pharmaceutical Online is part of the Life Science Connect media group. The publication provides in-depth articles intended for professionals who are actively involved in the development, manufacture, packaging, and distribution of small molecule products that have been approved by the US Food and Drug Administration.