Automation in pharmaceuticals & biotech production and factory design
Integrating all relevant functional areas into the corresponding IT systems and automation components is the basis for an efficient design of complex production processes. This is the speciality of our Manufacturing IT team.
ioDigitalSolutions manages and coordinates all processes prior, during and after the implementation of your IT system – from specifications through to acceptance tests. This includes the interfaces to the ERP system (SAP and others) and the machines, to material flow control and to the laboratory equipment. We determine the specific requirements for the subsystems and help you select the best implementation partners for your specific needs.
From ERP to the machines: we plan and design individual automation solutions and ensure optimal compatibility between the IT systems across all levels of the production process.
We are a member of NAMUR, the International User Association of Automation Technology in Process Industries, that serves as a forum for regular knowledge and information exchange. As such, we can always offer our clients leading edge know-how to tap the potential of new value chains.
From risk analysis to performance qualification – validation with the MES experts: Production processes in the pharma industry are subject to extensive regulatory requirements. IT systems that influence product quality must be validated and require documented proof that they comply with the prescribed criteria. Companies therefore have to invest a lot of effort in the documentation, regardless of whether processes, equipment or software need to be validated.
With our team of experienced pharmaceutical planners and IT consultants, ioDigitalSolutions will guide you through the entire validation process. We always apply the V-model and follow the Good Automated Manufacturing Practice (GAMP) Guide and/or the guidelines of the Food and Drug Administration (FDA).
Manufacturing IT in detail
1. 1. Concept, basic design and tendering
- Development of an automation concept (IT system architecture), a long-range plan (LRP) and an implementation roadmap
- Determination of the system requirements and drafting of the user requirement specifications (URS) for the various areas
- Drafting Risk Analysis I and a validation plan
- System selection
- Decision-making: Manufacturing Execution System (MES) and Electronic Batch Records (EBR)
- Drafting and evaluating concepts for integrating track & trace requirements depending on the target markets
- Preparation of the technical sections of the tender documents
- Preparation and coordination of the bidder list
- Conducting the tendering process
- Specialist assistance with bidder selection and contract award decisions
- 2. Detailed design
2. Detailed design
- Conducting workshops for defining the functional specifications with the supplier and with the manufacturers of adjacent systems
- Checking and approving the functional specifications provided by the supplier
- Development of the design qualification
3. Management and supervision of the implementation process
ioDigitalSolutions will be pleased to guide you through the implementation phase.
- Implementation management with project status monitoring and organisation
- Deviation and change management
- Monitoring of interface tests, system installation and integration
- Preparation and supervision of the acceptance tests (FAT, SAT)
4. Qualification & validation
- Drafting Risk Analysis II
- Drafting the IQ, OQ and PQ test plans
- Planning and coordination of validation tests
- Carrying out IQ, OQ and PQ test plans
- Planning and coordination of commissioning activities
- Defect and default management (in the event of cost increases or defective deliveries caused by suppliers, we offer the appropriate negotiation services on your behalf)
- Inspection of commissioning documents
- Performance and documentation of validation activities (if and as required)
- Ramp-up management
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