Our expertise, your benefit!
ITWorx4you offers consulting and engineering services worldwide for pharmaceutical manufacturing operations. With over 50 years of combined experience on our team, we are the ideal partner to support companies in selecting, implementing, and optimizing process-supporting systems — practical, efficient, and tailored to your needs.
ITWorx4you at a glance
50 Years…
…of experience and in-depth knowledge in the life sciences and pharmaceutical industry
Extensive Expertise…
…in analysis & design, project and program management, documentation, and validation
Globally Active…
…we provide consulting and engineering services for pharmaceutical manufacturing operations
Flexible Support…
Your Ideal Partner…
…for the selection, implementation, and optimization of process-supporting systems
An Innovative Team…
…that thinks ahead, co-develops, and helps shape the future
Our strengths in the regulated environment of the life sciences and pharmaceutical industry lie particularly in our four core services.
Services
e support our clients worldwide – remotely or directly on site. With technical expertise, in-depth knowledge, and commitment, we ensure your project reaches its goal safely and successfully.
Analysis
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An isolated initiative rarely leads to the achievement of strategic goals or manufacturing excellence. Successful approaches are always based on a comprehensive analysis of established processes and the company's accumulated experience.
- Organizational, process, and system analysis
- Alignment with corporate and project objectives
- Development of the final outcome
Concept Development
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There are many systems designed to support processes. We identify the one that best fits our client’s company and its specific requirements. As independent specialists, ITWorx4you provides the right tools and methods and actively supports clients throughout the entire evaluation process. From the creation of the RFP (Request for Proposal), taking all relevant aspects into account, to the final shortlist and presentation to management — we cover it all.
- Creation of the URS (User Requirements Specification)
- Interactive, client-specific development of the RFP
- Full execution of the RFP process, including vendor coordination
- Vendor assessment
- Preparation of the final shortlist
- Use case development for system demonstrations
- Facilitation of system presentations
Project & Program Management and Documentation
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he long-term success of a system implementation depends heavily on the strength of the project and program management behind it. Key to this success are robust risk management and a shift away from purely technical considerations. Our focus lies on holistic business change management, integrating people, processes, and technologies. With our expertise and ITWorx4you’s proven methods, we actively guide our clients through a structured, multi-phase design process, as well as an efficient implementation and documentation phase. Especially in multi-site programs, it is not sufficient to simply replicate a single-site project across all locations. Site- specific and individual harmonization requirements must also be considered.
- Targeted project management for specific challenges
- Business change management
- Documentation in accordance with GAMP 5 and applicable regulations
- Multi-site program management
Validation, Validation Support & Go-Live
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When implementing a process-supporting system, nothing works well without quality management. Reproducible results are essential for regulatory compliance. This requires strong quality management embedded directly in the project, along with the resulting validation activities. ITWorx4you takes over this responsibility for our clients, providing support for quality management as well as tailored validation and documentation services as needed. Additionally, ITWorx4you actively supports the go-live phase and the entire system lifecycle in close coordination with the client.
- Preparation of required validation documentation
- Support and execution of FAT/SAT, IQ/OQ/PQ
- Preparation of validation reports
- Lifecycle management, including for corporate standards
- Employee training, train-the-trainer programs, and training concepts
Our Team
Jobs
Then you’re in the right place!
What you should bring to the table:
→ Analysis & concept development
→ Project and program management
→ Documentation and/or validation
Send your application to:info@itworx4you.com – because we’ve got a lot to offer:
References
A selection from our client portfolio shows: Successful projects are built on in- depth expertise, collaborative partnerships, and tailored solutions designed specifically for your business.
Whether global pharmaceutical corporations, mid-sized life science companies, or specialized production sites – our clients trust in our expertise in analysis, implementation, and validation.
See for yourself – we look forward to making your project a success as well.
Our Partners
“Do the best you can until you know better.
Then, when you know better, do better.”
Maya Angelou
Get In Touch
+49 152 53734619
ITWorx4you GmbH
Sendlingerstrasse 60
80331 Munich
