A growing variety of variants, shorter product life cycles and parallel product launches are significantly increasing the pace of technology transfer and production processes. As a result, existing regulatory requirements must be met more frequently, more quickly and consistently. This is a challenge that can only be managed through the consistent digitalisation and automation of the underlying processes.
In practice, however, fragmented ERP and MES landscapes are holding back progress.
Duplicate master data maintenance, inconsistent process models and complex, manual validation and approval cycles prolong batch releases, increase the effort required for change management and compliance, and hinder scalable, global rollouts.
The vision is clear: an integrated, GxP-compliant end-to-end manufacturing suite that consistently ensures regulatory compliance, significantly reduces validation and batch release times, and combines global standards with the necessary local flexibility.
A centralised, versioned Master Batch Record (MBR) forms the backbone of manufacturing execution: it enables consistent, cross-site control and documentation of production processes and lays the foundation for standardised, audit-proof execution.
The inheritable nature of formulations, process logic and parameters accelerates the ramp-up of new products, from tech transfer to series production. The new validation process thus benefits from B predefined, reusable standardsB that significantly shorten validation and release times and minimise the overall effort per cycle.
Higher throughput and shorter turnaround times Significantly shorter batch release cycles thanks to a central master batch record
Review by Exception shifts the focus of the traditional batch review from a comprehensive examination of the Electronic Batch Record to a targeted assessment of documented deviations. Whilst the MBR defines the target process, the EBR maps the actual process, including deviations and risk classification. Process steps that comply with regulations are automatically approved. This results in shorter review and approval times and full audit assurance.
Launching in a few weeks – from product development to production Rapid product launch without backlogs (Time2Market)
Modelled recipes, automated order generation and parameter-based workflows enable a high rate of technology transfer. New products move more quickly from development to production, without system disconnects or redundant configuration.
Truly AI-ready – a single source of truth thanks to a central MBR A data platform for real-time transparency and business AI
The integrated S/4HANA and SAP DM architecture eliminates data silos and manual reconciliation. Shop floor events feed directly into planning and promise date updates. Predictive quality, optimised scheduling and real-time insights are made possible by a consistent data foundation.
Initial situation:
Manual full checks, long quarantine periods, delayed market availability
With integrated architecture:
Business Impact:
Initial situation:
Separate MES instances for each site, significant validation effort
With integrated architecture:
Business Impact:
Initial situation:
Duplicate maintenance of routings, instructions and tolerances in ERP and MES
With integrated architecture:
Business Impact:
End-to-end expertise in SAP S/4HANA, SAP Digital Manufacturing, QM and compliance processes.
With cbs, you have a partner at your side who combines strategic thinking with operational excellence. We provide you with comprehensive support – from the initial definition of objectives right through to the long-term integration into your systems and processes.
Thanks to our end-to-end expertise across the entire value chain – from design to operation –, we put your data into the right context, create clarity around processes and enable informed decisions at every level. In doing so, we combine a deep understanding of processes with state-of-the-art technology – delivering real results rather than mere concepts.
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