Enterprise Ressource Planning
Smart ERP validation - the key to Pharma 4.0
Due to their complexity, the implementation and operation of enterprise resource planning systems (ERP) in highly regulated industries generate particularly high costs due to the necessary CSV. We address the problem of the high cost of recurring CSV with intelligent and proven methods that can permanently reduce these validation costs and ensure compliance more easily. By using CSA-compliant validation approaches, we ensure that your ERP system is validated and re-validated efficiently and reliably. Our validation processes are designed to optimize implementation time, reduce costs and improve quality. Risk-based - automated - critically analyzed.
Our solution
INCONSULT has in-depth know-how of the pharmaceutical industry, which helps us to realize problems and challenges for ERP systems in the GxP context and to assess the criticality of the processes. This applies in particular to master data and QM processes, which have a direct impact on product quality. Combined with many years of experience in ERP validation, project management, organizational change management and validation, we can develop customized, well thought-out and compliant solutions for your company's specific requirements. We work closely with you to ensure that a successful implementation or conversion of an existing ERP system (e.g. SAP S/4HANA, Microsoft Dynamics) is guaranteed. We ensure that both your business requirements and GxP standards are taken into account.
ERP in the cloud
Cloud systems are becoming increasingly important, particularly in the area of ERP, due to their flexibility and cost efficiency. Inconsult offers comprehensive support in validating your cloud solutions, with our experienced team effectively managing relationships with cloud providers. In addition, we specialize in qualifying cloud infrastructures to ensure the integrity and security of your data in the cloud with our support.
Your advantage
By implementing and validating an ERP system with our experts, you benefit from efficient data-driven approaches using ALM tools and assured compliance. We work with you to ensure that the implementation of your ERP system is successful while enabling a fast, smooth transition and continuous support. At the same time, we build the bridge to local teams and enable a successful transition to the new system environment in local roll-outs.
Why ERP with INCONSULT?
- Targeted & efficient project management: The successful implementation of an ERP system requires coordination, planning and structuring. Our experienced project managers ensure a structured and logistical implementation of the project - also using agile methods and data-driven approaches
- Comprehensive organizational change management: a change requires acceptance - especially for global cloud systems, a change such as the transformation or introduction of an ERP system must be sensibly promoted and communicated. Our experts in OCM know that such a change must be sustainable
- Holistic thinking & action: We support the entire system lifecycle - with our experience in the areas of vendor audits, validation, testing, periodic reviews and implementation of role concepts
- We think critically: The criticality of processes is crucial for ERP systems - which processes need to be considered to ensure data integrity and compliance in the GxP environment? We know that master data and QM processes are the key to smart validation
- Elaboration of risk analyses: An indispensable part of validation - we quickly get you to validate the right thing and carry out a systematic and methodical assessment of the risks
- Reduction of test effort: We bring clarity to the mass of requirements and test data, reduce test effort and at the same time increase efficiency and accuracy in testing - e.g. by means of test automation of regression tests with UiPath.
- Training and support: Our consultants ensure that your employees are - and remain - fit for validation throughout the entire lifecycle.
- Quality assurance in data migration: by designing migration strategies, validating data and carrying out migration tests
- Effective vendor management, vendor audits and qualification of cloud infrastructure
- Optimization of the operating phase - support on operational concept
- Adaptation of work instructions
- Administrative processes (e.g. compliant with ITIL)
- Change management
- Configuration control
- Master data management processes
- Business continuity
- Periodic reviews
- Decommissioning of legacy systems
Technologies
ALM tools
Modern application lifecycle management tools can be used to implement a data-driven approach that supports both classic waterfall and agile methods. We offer many years of experience and highly qualified experts in the use of ALM tools, with the aim of making it easier for our customers to switch to a data-driven model and benefit sustainably in their operations.
Test automation
The use of state-of-the-art test automation tools and methods not only speeds up test execution, but also improves the accuracy and repeatability of tests. Our consultants are adept at developing customized automation strategies that are tailored to your specific requirements. This includes the identification of suitable test cases for automation, the selection and integration of suitable test tools as well as the creation of automated test scripts and their execution.