Practical Aspects of On-Demand Access to Critical Process Data from Paper Records and Process Databases for Monitoring and Control of a Biopharmaceutical Manufacturing Process

This case study of Merck Serono's approach will review the methods used and benefits gained when manufacturers have on-demand access to data stored in paper records combined with production data in other disparate sources (e.g., MES, LIMS, Historians, CAPA, other databases and data warehouses) in one integrated, validatable environment.

Case study key learnings include

• Reflect all the potential process steps
• Record all the process parameters that might be varied or measured (including meaningful contextual parameters) in a timely manner
• Include traceability of critical raw materials (e.g., cell culture powder lots) or critical preparations (e.g., chromatography column packing)
• Enable automatic accounting for process genealogy to enable easy correlation of upstream parameters with downstream outcomes

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