Global Process Harmonization for Future-Ready Manufacturing
Success Story MES Business Process Harmonization
How a global pharmaceutical company standardized MES-driven processes to boost efficiency and to create a future-ready digital manufacturing environment.
Key Facts:
#1 CHALLENGE
Our client, a global leader in pharmaceutical manufacturing, faced a critical need to standardize its Manufacturing Execution System (MES) processes across its Drug Substance (DS) network. This was due to a combination of factors:
1. Process Diversity: The client’s global DS network spanned five sites operating with two distinct MES platforms and varying degrees of digital maturity. This fragmented landscape led to inefficiencies in recipe design, batch reviews, exception handling, and governance.
2. Compliance and Scalability: In an industry governed by stringent regulatory standards, inconsistencies across sites increased the risk of non-compliance and slowed down the scalability of MES solutions and lowered its ability to integrate with other enterprise-wide initiatives like ERP and LIMS platforms.
3. Innovation Bottlenecks: Without harmonized processes, the client encountered redundant efforts during MES implementation, hindering its ability to leverage innovations such as Review by Exception, digitalized workflows, and real-time data integration.
To address these challenges, the client initiated a Business Process Harmonization (BPH) program for its DS network to align processes and systems with its company goals of operational efficiency, fast patient delivery, and robust processes.
Key Facts:
5 global sites involved
40+ contributors across functions and locations
24 harmonization topics resolved
5 global sites involved
40+ contributors across functions and locations
24 harmonization topics resolved
#1 CHALLENGE
Our client, a global leader in pharmaceutical manufacturing, faced a critical need to standardize its Manufacturing Execution System (MES) processes across its Drug Substance (DS) network. This was due to a combination of factors:
1. Process Diversity: The client’s global DS network spanned five sites operating with two distinct MES platforms and varying degrees of digital maturity. This fragmented landscape led to inefficiencies in recipe design, batch reviews, exception handling, and governance.
2. Compliance and Scalability: In an industry governed by stringent regulatory standards, inconsistencies across sites increased the risk of non-compliance and slowed down the scalability of MES solutions and lowered its ability to integrate with other enterprise-wide initiatives like ERP and LIMS platforms.
3. Innovation Bottlenecks: Without harmonized processes, the client encountered redundant efforts during MES implementation, hindering its ability to leverage innovations such as Review by Exception, digitalized workflows, and real-time data integration.
To address these challenges, the client initiated a Business Process Harmonization (BPH) program for its DS network to align processes and systems with its company goals of operational efficiency, fast patient delivery, and robust processes.
#2 APPROACH
The client partnered with msg industry advisors to lead the Business Process Harmonization initiative. This effort was structured around aligning local site operations with a global MES framework.
A key principle behind this Business Process Harmonization (BPH) initiative was to “Discuss once, implement multiple times”.
The approach was divided into five key phases:
Phase 1: Comprehensive Site Assessment
The initiative began with in-depth site interviews involving over 40 participants. This phase aimed to identify variances in system landscapes, governance, and digital maturity. The client’s key MES processes – such as batch reviews, recipe design, and equipment management – were analyzed to map gaps and opportunities.
Phase 2: Clustering and Work Package Development
Based on the site assessments, 33 harmonization topics were identified and prioritized into six work packages:
- Data Management
- Equipment Management
- Manufacturing Processes
- Recipe Design & Verification
- Review by Exception
- Process Architecture & MES Integration
These clusters provided a structured approach to addressing both global and site-specific challenges.
Phase 3: Regional and Global Harmonization Workshops
Global and local workshops were held to foster collaboration between different regions and sites and align stakeholders on harmonization goals and best practices. msg industry advisors provided technical expertise and facilitated iterative discussions to ensure alignment with involved sites and the client’s global initiatives, such as the global SAP program, global Product Lifecycle Management (PLM), and global LIMS.
Phase 4: Documentation and Governance Formalization
The harmonization outcomes have been documented to provide detailed guidelines to support the implementation of harmonized processes - discuss once, implement multiple times – as well as broad stakeholder engagement.
Phase 5: Integration and Future Deployment
Harmonized processes were integrated into the client's MES framework, ensuring readiness for future deployments. The unified approach reduced redundancy and created a scalable model for digital transformation projects.
#3 OUTCOME
Using this systematic approach, msg industry advisors were able to provide a structured methodology to align local site practices with the client's global standard and establish a robust governance model for MES-driven processes. As a result, the Business Process Harmonization initiative delivered transformative results for the client’s DS network:
Unification and Compliance
- Streamlined Workflows: Standardized MES recipes, exception management, and governance processes improved consistency and compliance across all sites.
- Regulatory Assurance: Harmonization minimized variability in manufacturing operations, reducing risks during regulatory inspections and audits.
Operational Efficiency
- Accelerated Batch Reviews: The harmonization of paperless workflows and Review by Exception significantly reduced manual review efforts, enabling faster batch releases.
- Efficient Deployments: The harmonized framework simplified MES implementations, reducing deployment effort and human resources.
Enhanced Digitalization
- Maturity: Sites can be transitioned from manual, unharmonized operations to fully harmonized and digitized workflows, aligning with the client’s vision of robust, efficient, and scalable processes.
- Seamless Integration: MES systems will be effectively integrated with enterprise architecture consisting of e.g. ERP, LIMS, DCS and PLM, to create a connected digital ecosystem.
#4 OUR IMPACT
Where msg industry advisors make the difference:
- End-to-End Guidance: msg industry advisors led the client from initial assessments to harmonized process formalization, ensuring seamless execution and measurable results.
- Scalable Solutions: The creation of reusable templates and guidelines enabled the client to implement harmonized processes globally, reducing operational redundancies.
- Expertise in Pharma Digitalization: msg industry advisors’ deep knowledge of MES systems and its pharmaceutical processes and requirements ensured operational excellence and GxP compliance.
#2 APPROACH
The client partnered with msg industry advisors to lead the Business Process Harmonization initiative. This effort was structured around aligning local site operations with a global MES framework.
A key principle behind this Business Process Harmonization (BPH) initiative was to “Discuss once, implement multiple times”.
The approach was divided into five key phases:
Phase 1: Comprehensive Site Assessment
The initiative began with in-depth site interviews involving over 40 participants. This phase aimed to identify variances in system landscapes, governance, and digital maturity. The client’s key MES processes – such as batch reviews, recipe design, and equipment management – were analyzed to map gaps and opportunities.
Phase 2: Clustering and Work Package Development
Based on the site assessments, 33 harmonization topics were identified and prioritized into six work packages:
- Data Management
- Equipment Management
- Manufacturing Processes
- Recipe Design & Verification
- Review by Exception
- Process Architecture & MES Integration
These clusters provided a structured approach to addressing both global and site-specific challenges.
Phase 3: Regional and Global Harmonization Workshops
Global and local workshops were held to foster collaboration between different regions and sites and align stakeholders on harmonization goals and best practices. msg industry advisors provided technical expertise and facilitated iterative discussions to ensure alignment with involved sites and the client’s global initiatives, such as the global SAP program, global Product Lifecycle Management (PLM), and global LIMS.
Phase 4: Documentation and Governance Formalization
The harmonization outcomes have been documented to provide detailed guidelines to support the implementation of harmonized processes - discuss once, implement multiple times – as well as broad stakeholder engagement.
Phase 5: Integration and Future Deployment
Harmonized processes were integrated into the client's MES framework, ensuring readiness for future deployments. The unified approach reduced redundancy and created a scalable model for digital transformation projects.
#3 OUTCOME
Using this systematic approach, msg industry advisors were able to provide a structured methodology to align local site practices with the client's global standard and establish a robust governance model for MES-driven processes. As a result, the Business Process Harmonization initiative delivered transformative results for the client’s DS network:
Unification and Compliance
- Streamlined Workflows: Standardized MES recipes, exception management, and governance processes improved consistency and compliance across all sites.
- Regulatory Assurance: Harmonization minimized variability in manufacturing operations, reducing risks during regulatory inspections and audits.
Operational Efficiency
- Accelerated Batch Reviews: The harmonization of paperless workflows and Review by Exception significantly reduced manual review efforts, enabling faster batch releases.
- Efficient Deployments: The harmonized framework simplified MES implementations, reducing deployment effort and human resources.
Enhanced Digitalization
- Maturity: Sites can be transitioned from manual, unharmonized operations to fully harmonized and digitized workflows, aligning with the client’s vision of robust, efficient, and scalable processes.
- Seamless Integration: MES systems will be effectively integrated with enterprise architecture consisting of e.g. ERP, LIMS, DCS and PLM, to create a connected digital ecosystem.
#4 OUR IMPACT
Where msg industry advisors make the difference:
- End-to-End Guidance: msg industry advisors led the client from initial assessments to harmonized process formalization, ensuring seamless execution and measurable results.
- Scalable Solutions: The creation of reusable templates and guidelines enabled the client to implement harmonized processes globally, reducing operational redundancies.
- Expertise in Pharma Digitalization: msg industry advisors’ deep knowledge of MES systems and its pharmaceutical processes and requirements ensured operational excellence and GxP compliance.
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