Services
Our PAS-X Principal Consulting and Client Advisory Services are designed to accelerate your digital transformation and drive operational excellence.
Many bio and pharmaceutical companies are facing increased challenges in the life science industry and especially in the manufacturing IT, like supply chain disruptions due to resource and supplier issues, problems in manufacturing leading to drug shortages, product quality & data integrity issues, enhanced needs for visibility and tracking of products as well as increased requirements on reducing time to market from process development over manufacturing to patient. In addition, there is high-cost pressure.
Körber’s PAS-X Strategic Consulting, also known as Principal Consulting and Client Advisory, is your team of experts supporting your individual requirements and initiatives throughout your entire digitization process. We can help you define goals and strategies for your manufacturing IT and leverage the potential of Körber’s PAS-X product suites.
With us, you have a competent partner with comprehensive industry knowledge at your side on your path to digitalization right from the start.
It is a special bond that connects Novo Nordisk with Körber: Körber supports the digital ambitions of the global healthcare leader and acts as trusted MES partner, ecosystem provider, and rollout service partner.
We advise and guide you through the complete digitization process, from the start of the strategic analysis and definition phase, through the whole project or program execution, to concrete optimization potential in operations, as well as in quality assurance, compliance and operational excellence.
While other MES services provider focusses only on a very general and high-level provisioning of ideas suitable for many MES solutions, we will deep dive into PAS-X specific benefits and will help you to achieve your specific goals by bringing to you all our PAS-X expertise gained during many strategic projects with multiple customers worldwide.
Regardless of the size of your current business and the digital maturity of your organization, we target our services on your individual needs, knowing this industry and its challenges as no other.
Let your digitalization initiative become successful. We help you understand what matters and support you in initiating, planning, executing, and optimizing your project or program.
The Pharma 4.0 Strategy gives a high-level introduction to the pharmaceutical industry using advanced digital technologies, such as AI, big data analytics and IoT. This introduction is focused especially on the manufacturing part using PAS-X MES to achieve a digital transformation, enabling smart manufacturing for faster production and optimized supply chains, operational excellence and reducing time to market.
The Digital Maturity and Readiness Assessment evaluates an organization's current state and preparedness for digital transformation achieving strategic alignment of digital initiatives with business goals and enhanced operational efficiency through process optimization and maximizing return on technology investments and enabling quick adaptation to market changes.
The Digital Plant Blueprint maps out customers’ existing and future digital ecosystem identifying the best fitting hosting options in cloud (private, public, hybrid) or on-premise for the integration of PAS-X into their ecosystem ensuring a best practice functional distribution and integration with other required systems and defining the needs and setup on customer side to operate and maintain these solutions improving productivity, regulatory compliance, scalability, and cost savings through optimized processes and cloud-enabled efficiency.
The PAS-X Portfolio & Roadmap Planning supports the planning of the scope of the PAS-X products and defines a clear roadmap for its implementation increasing visibility on requirements and create a clear URS adapted to the individual needs offering scalability and flexibility with growth of the company reducing downtimes and lowering operational costs.
The Business Case & NPV Assessment for implementing a PAS-X solution describes the overall proposed solution, benefits, implementation plan, risk analysis, and detailed financial analysis covering assumptions, cost breakdown, benefit estimation, cash flow projections and NPV calculation providing financial justification by calculating the net present value of the investment, helping stakeholders make informed decisions.
The PAS-X Implementation Strategy describes how to successfully implement a PAS-X solution focusing on all impacting areas like objectives, scope of the solution, an implementation plan, change and risk management as well as integration strategies paired with GMP relevant aspects within Life science improving efficiency, quality, and regulatory compliance.
The MES Center of Excellence (CoE) Blueprint focusses on first analyzing the individual organizational AS-IS situation performing focused interviews with all required stakeholders, secondly defining together the improvement targets and finally creating a report with recommendations and activities to follow ensuring a structured approach to MES management, fostering efficiency, compliance, and innovation, ultimately aligning with organizational goals and enhancing manufacturing operations.
Our Best Practice Program Guidelines include guidelines for governance, project planning, system selection, and design of the PAS-X solution emphasizing on operational best practices, performance measurement, continuous improvement, and post-implementation support ensuring a structured, compliant, and efficient PAS-X deployment, enhancing manufacturing efficiency and product quality.
Our Best Practice Project Rollout Plan includes the definition of project phases and milestones, site readiness assessment, as well as a cutover strategy and planning covering change management, training, integration, data migration, and validation. It ensures a smooth, efficient, and compliant MES implementation, enhancing manufacturing operations, product quality, and regulatory compliance.
In pharmaceutical manufacturing, MES operational activities can be managed in-house or outsourced. We will guide you to make the right choice between in- and outsourcing by analyzing your specific organizational setup and recommend different scenarios based on the typical roles required during operations and the level of knowledge / skills available. This will help you to balance in-house and outsourced tasks and responsibilities to leverage strengths and resources effectively.
Our PAS-X Cutover Plan ensures a seamless transition from your current system or situation to a new PAS-X system. The cutover strategy details the approach, readiness criteria, and go/no-go checkpoints ensure minimal disruption and effective operational continuity before, during and after transitioning to a new PAS-X system.
The Migration Strategy & Archiving details the migration approach, describes the data migration plan, system integration, and validation for compliance ensuring a seamless migration, data integrity, regulatory compliance, and enhanced operational efficiency.
Our Best Practice Shopfloor Execution Strategy describes the required governance structure, and detailed SOPs covering inventory, recipe (GMBR) and logbook management, Electronic Batch Recording (EBR) optimizations, maintenance, HSE policies, and continuous improvement. This comprehensive approach ensures efficient, compliant, and high-quality manufacturing operations, aligning with organizational goals and regulatory requirements, ultimately enhancing overall shopfloor performance.
The Data Analytics & Shopfloor Connectivity Blueprint describes the objectives, and scope especially for data management and storage, real-time monitoring, analytics tools, and techniques as key elements operational excellence enhancing data-driven decision-making, operational efficiency, and connectivity on the shopfloor.
The Program & Project Transition Management includes project handover procedures, documentation requirements, training and support for new teams, and performance metrics to monitor progress and details a comprehensive transition ensuring smooth project transitions, minimizing disruption and maintaining operational continuity.
The Global Process Harmonization outlines governance and leadership roles, standard operating procedures (SOPs) development, and process alignment across all sites including process mapping, gap analysis, and integration strategies of harmonized GMBRs. This illustrates successful process and recipe harmonization efforts ensuring consistent, efficient, compliant and standardized processes across the global organization.
The Master Batch Record (MBR) Lifecycle Management describes best practices implementing state-of-the-art recipes considering the entire MBR lifecycle ensuring accurate, compliant, and efficient batch record handling throughout its lifecycle.
The Global Validation Methodology describes validation activities, and its harmonization across production sites globally. It focusses on risk assessment, validation planning, execution, and documentation, covering equipment, processes, and software. Standardizing and harmonizing validation on a global level ensures consistent, compliant, and efficient validation practices reducing site specific validation efforts as well as project time drastically.
Our Paper SOPs to Master Batch Record (MBR) Guideline outlines the transition strategy from paper-based SOPs to digital MBRs, standardizing MBR templates, integrating with MES, and ensuring regulatory compliance including data migration, validation processes, and version control providing insights into successful transitions, ensuring accurate, compliant, and efficient batch record management.
The Audit Trail Review Guideline describes how to conduct successfully audit trail reviews in combination with PAS-X detailing procedures for regular review, documentation, and reporting of audit trails in combination with quality management systems. It illustrates effective audit trail review processes, ensuring transparency, accountability, and compliance reducing the efforts associated with QA reviewing by using a risk-based approach and relying on PAS-X specific functionality.
Our best practice 360-degree Assessment during operations includes key elements like evaluating employee / process performance, teamwork, leadership, and operational efficiency through feedback from different stakeholders. It emphasizes data collection methods, analysis, and documentation while focusing on risk management and creating action plans based on feedback enhancing operational performance and employee development
Our Best Practice Program & Project Advisory focuses on governance, roles, and responsibilities for program and project management establishing best practices for project planning, execution, and monitoring, ensuring compliance and quality standards illustrating successful project management, enhancing operational efficiency, compliance, and overall project success.
The MBR (Master Batch Record) / EBR (Electronic Batch Record) Optimization assesses current MBR/EBR processes, identifying inefficiencies, and implementing improvements ensuring accurate, efficient, and compliant batch record management using PAS-X functionality.
The Instant Batch Release strategy describes the implementation of real-time batch release processes using a fully integrated PAS-X to Level 2, 3 and 4 systems ensuring regulatory compliance, data integrity, and seamless communication between production and quality departments detailing procedures for validating instant release criteria. This strategy will reduce time to market and overall QA costs.
Our Batch Throughput Optimization strategy is focused on enhancing batch processing efficiency by analyzing current processes, identifying bottlenecks, and implementing lean manufacturing principles covering also technology integration (e.g., PAS-X to Level 2 real-time monitoring), process mapping, and workflow optimization increasing production speed, reduces overall production costs while maintaining quality and compliance standards.
Experienced client consultants, mentor and support you in defining the goals and strategies for your manufacturing IT, with a focus on Pharma 4.0, digitization in the life science industry, and emerging technologies.
