Your partner for customised automation in the pharmaceuticals and biotech production sector

When designing complex production processes, it is essential that operational areas are all 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 ERP 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.

From risk analysis to performance qualification – validation with the MES experts

Production processes in the pharmaceuticals industry are subject to extensive regulatory requirements. IT systems that influence product quality must be validated and there must be documented proof that the IT systems comply with the predefined criteria. These documentation requirements for the validation of processes, equipment or software entail vast expenditures of time, effort and funds. As an experienced planner for the pharmaceuticals sector and a long-standing IT consultancy, we guide you through the entire validation process. In doing so, we apply the V-model (aka ‘waterfall approach’) and the best practice guidelines of Good Automated Manufacturing Practice (GAMP) and the Food and Drug Administration (FDA).

Key competencies in validation:

  • Drafting of user requirement specifications (URS)
  • Risk analyses
  • Development of functional specifications (FS) with the supplier
  • Planning and management of validation tests

References

io-consultants is your experienced partner for the reliable and successful validation of IT and manufacturing execution platforms. The many prestigious companies who rely on us for assistance with conducting their validation processes include:

Methodic automation solution planning

When developing automation solutions for pharmaceuticals and biotech production, we use our own custom-developed methodology, which we regularly adapt to accommodate changing 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

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    • 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 organisation
    • 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

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    • 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
  • 5. Commissioning

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    • 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 ties in professional technical know-how and project management expertise. This way, we ensure that your new production begins successfully and on schedule.

Please contact us 

Marco Lederle Partner Phone: +49 (0) 62 21 / 379-193

Other services and industries you may be interested in

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.

About io‑consultants

io-consultants provides integrated consulting, design and planning services for production, logistics and supply chain management, as well as for architecture and IT projects. Since our launch in 1958, we have been helping our clients improve their supply and value chain with a wide range of services: from developing ideas into strategies to implementing complex industry projects as a lead consultant.