Embedded EM discipline that closes qualifications.
Damgaard Solutions embedded a senior EM specialist in the Grade D dissolution area at Novo Nordisk Kalundborg, running EM execution, PEMS deviation handling, and contamination investigation through CCTV and microbiological screening to close PPV PL1 on time, GMP compliant.
Late-Stage Entry, Complex Scope, Hard Deadline
Damgaard Solutions joined a high-stakes Process Performance Validation project at Novo Nordisk Kalundborg shortly before qualification was due to begin. PPV PL1 covered a new API Dissolution facility integrating robotics, a PAS-X manufacturing execution system, and adapted HVAC. Several rooms still needed approval for qualification. EM data was generating excursions that required investigation. Operator readiness across cleaning procedures and product handling was uneven. The project had real momentum, but the path to a clean PPV close was crowded with overlapping technical and documentation challenges.
EM Execution, Trend Analysis, and Contamination Investigation in One Embedded Role
Damgaard Solutions provided embedded EM and PFV support inside the Dissolution area, from room qualification readiness through PFV execution, deviation handling, and operator enablement. One specialist, working alongside the operator and EM teams, with daily visibility into the PPV PL1 status.
1. Room qualification readiness through structured GMP checks
Performed room inspections, cleaning verification, and deviation handling to drive qualification approval. Reviewed and optimized cleaning rationales for compliance and efficiency, removing ambiguity from cleaning procedures before they became findings.
2. EM execution with PEMS trend analysis and excursion investigation
Managed environmental monitoring across the Dissolution area, including data analysis, deviation handling, and trend reporting in PEMS. Investigated EM excursions through CCTV review and microbiological screening, identifying contamination sources and supporting corrective actions before excursions escalated into PPV findings.
3. Test plans, validation reports, and TIMS execution
Developed test plans and validation reports and executed activities in TIMS. Built documentation discipline into the PFV workflow so that traceability, deviations, and acceptance criteria were captured at the moment of testing rather than reconstructed afterwards.
4. Operator training and visual management for sustained compliance
Trained operators in procedures and documentation standards. Prepared shift schedules and visual management boards that kept the team aligned on EM status, deviations, and open actions. Coordinated daily with QA, project management, stakeholders, and external partners to remove blockers before they hit the qualification path.
Elsebeth Hjelm Lindstrøm is a Senior Specialist in Environmental Monitoring at Damgaard Solutions, with deep expertise in EM execution, PEMS trend analysis, and PPV/PFV support across GMP manufacturing environments. She is known for joining late-stage qualification efforts and bringing the operational discipline, documentation rigor, and team coordination required to close on time.