Your partner for customized automation in the pharmaceuticals and biotech production sector
When designing complex production processes, it is essential that all operational areas are integrated into the IT systems and automation processes. Our Manufacturing IT specialists make sure of that.
We guide you through and coordinate the implementation of your IT systems from specifications drafting through to standard operations and acceptance tests. The interfaces to the ERP systems (such as SAP), integration of the machinery, material flow control and lab equipment – all these aspects are factored in when we draft the specifications for the individual system components and help you find the right implementation partner.
From the ERP system down to the machines – io-consultants plans and designs individual automation solutions and ensures excellent interaction between IT systems across all levels and production processes.
We are a member of NAMUR, the international User Association of Automation Technology in Process Industries, which provides regular information exchanges and access to the latest industry trends and developments. This membership enables us to offer you, our clients, a valuable head start in process and automation know-how and helps us tap new value-added potential for you.
io-consultants is your experienced partner for the reliable and successful validation of IT and manufacturing execution platforms. The companies who rely on us for assistance with conducting their validation processes include:
Methodical design of automation solutions
When developing automation solutions for pharmaceuticals and biotech production, we use our own custom-developed methodology, which we regularly adapt to accommodate changing client and regulatory requirements.
1. Concept, basic design, and tendering processes
- Drafting of automation concepts (IT system architecture), long-range plans (LRP), and implementation roadmaps
- Development of system requirements and drafting of user requirement specifications (URS) for the various areas
- Risk analysis 1, and creation of validation plans
- System selection
- Selection of an electronic batch record (EBR) system
- Target market dependent evaluation and drafting of concepts for integrating Track & Trace requirements
- Preparation of technical tendering documents
- Compilation and mutual coordination of the list of bidders
- Conducting of selection processes (incl. assessing eligibility criteria)
- Assistance with bidder selection and decision-making
2. Detailed Design
- Conducting workshops with suppliers and with manufacturers of peripheral systems, in preparation for defining the functional specifications (FS)
- Checking and approving the suppliers’ FS
- Drafting of design qualification
3. Conducting the implementation process
- Implementation management with project status monitoring and organization
- Deviation and change management
- Monitoring of interface tests, system installation and system integration
- Preparation and supervision of the acceptance tests (FAT, SAT)
4. Qualification and validation
- Risk analysis 2
- Drafting of IQ, OQ and PQ test plans
- Planning and coordination of validation tests
- Processing of IQ/ OQ and PQ test plans
- Planning and coordination of activities for the start of standard operations
- Fault management, scope extension and reduction management
- Review of standard operations documentation
- Implementation and documentation of any validation activities
- Ramp-up management
Integrated project management
Qualification of operations and performance in perfect unison
IT validation and the development of automation concepts require professional project management expertise and sound IT experience – services that are often under-estimated. Our integrated proprietary project management system seamlessly brings together all the information provided by the various automation and software systems (such as ERP, MES), the hardware, technical infrastructure, TBE and the building technology to ensure transparency for all services – irrespective of their providers.
Our clients benefit from our holistic approach that incorporates professional technical know-how and project management expertise. This way, we ensure that your new production begins successfully and on schedule.
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As a lead consultant, we provide comprehensive services across a variety of disciplines – production, logistics, architecture and IT – and will oversee each stage of your project from the beginning right through to standard operations.