Validation

Experienced validation consultants

NIRAS's Validation Team (VAL team) can help pharma and Life Science companies ensure optimal utilisation of the production machinery. Our validation experts have deep insight into the production machinery within the Life Science industry, and they understand the importance of efficient and coherent processes.

Our consultants have extensive experience within production and solve tasks on everything from strategy, planning and testing to documentation and compliance in projects. They know that it is costly to establish and maintain the production machinery within Life Science companies, and that it is therefore important to ensure the best possible operation.

Creating efficient processes increases productivity. However, we are also aware that changes may not only increase production, but may also lead to challenges in coordinating the many stakeholders who are part of the process.

If you want to succeed in making changes to optimise the production and increase productivity, it requires specialists in validation. Our experts can help find the right changes to optimise the production, as well as ensure that the solutions are implemented in a safe way to allow normal operations to continue in parallel with the changes being carried out.

Coordination

Validation projects have many stakeholders, both internally and externally. Coherence and overview are therefore crucial to ensure a focus on what really creates value.

Our experts handle stakeholders at all levels of the organisation from the factory floor to the management corridor, and they can relate to and address several disciplines. In this way, we create an overview of the various tasks in the phases of the project.

Based on a risk-based and scientific approach, we ensure that the resources are used efficiently. Legislative requirements for equipment, production facilities and documentation are part of our core professional foundation to ensure compliance and coherence.

Professional knowledge sharing

Professionalism is the basis of our work, and the consultants in the team have experience and knowledge in a wide variety of areas. Our way of working is based on knowledge sharing and professional sparring.

When the individual consultant solves a task, it allows for internal problem solving. This means that professionally we are more versatile as we can draw on each other's knowledge and experience, which ultimately benefits our clients.

In other words: You are drawing on an interdisciplinary consulting company - not just one consultant.

Validation from A to Z

Projects have several phases, and the individual company's needs define which level we are entering. We help some clients set the level and prepare a general strategy for validation. For others, we plan specific projects, implement solutions or perform practical tasks.

Both the project and the operating organisation require the right match of competencies to ensure an optimal process. We can relieve the permanent team and ensure that our clients reach their goals, regardless of whether the need is for optimisation and revalidation of existing processes, installation of new equipment or new processes, expansion of the production, or something completely different.

Professionally, we are very versatile and understand that everything must be coherent. That is why we provide assistance on all levels and ensure that a solution works for the individual company's situation.

NIRAS’s expertise within validation

Below are some examples of the type of tasks that our validation experts have solved:

Production

• Cleaning validation
• Environmental monitoring, including aseptic production
• Automation
• IT validation
• Process validation
• Temperature mapping, including transport validation
• Decommissioning

Process optimisation

• Optimisation of existing processes, including lean and OEE
• Establishment and qualification of new processes
• Mapping of flow and troubleshooting at the individual steps
• ASTM2500E
• Project management
• Coordination of stakeholders

Equipment

• Qualification of equipment
• Bio-process, chemical process and production equipment
• Package lines
• Fill lines
• API manufacturing
• GMP documentation (RA, URS, DQ, IQ, OQ, PQ, SOPs, protocols, preparation of change cases, risk analyses, deviations, etc.)
• Validation of temperature-controlled rooms and equipment. Read more here.