Validation

Being able to guarantee that what you produce is of the same quality, every time, is at the heart of validation. Consistent quality and reliability is important not only to meet regulatory requirements, but also to provide confidence in the product. With the right expertise, the path to compliance is both cost-effective and tailored to the needs of validation and commissioning.

Vi Erbjuder

Quality and compliance at all levels

Validation is about ensuring that systems, processes and equipment comply with regulations. By verifying that everything works as it should, from the start of production to continuous production, you minimize risks and ensure the quality of your product and supporting systems.

Intelligent CSV

Minimize risks such as data loss and downtime while keeping quality, data integrity and patient safety in focus.

Regulatory certainty

Comply with GxP and other requirements, and reduce the risk of non-conformities and inspection remarks.

Effectiveness

Achieve the right balance between quality and efficiency to save time and resources.

Expert support

Access the best validation teams in the industry without building internal capacity.

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Hur vi gör skillnad

Industry-leading expertise & experience

Deep understanding of Life Science, with experience in Pharma, Biotech, Medtech, and Healthcare.

Holistic approach

We support the entire project lifecycle from concept and development to implementation and follow-up.

Flexibility in methods

The combination of proven ways of working and tailored solutions makes us adaptable to any need, from the start-up to the global organization.

Effective results

Through experience and a clear structure, we save time, resources and ensure a safer implementation of projects.

Insights

Ensure reliability and compliance

Selected customers within Validation

Our services in Validation

Validation of computerized systems

Validating that systems are reliable and comply with regulations and guidelines (such as GAMP) is essential to meet both regulatory requirements and business needs. We have deep and long-standing expertise in computerized systems validation (CSV), and have been offering training in the field for many years.

Validation of processes and equipment

In order to guarantee the quality of the product, it is essential that manufacturing processes and equipment are validated and maintained in a validated status. We provide a validation strategy that ensures in a structured and efficient way that each step of the process meets the requirements and quality attributes set.

Validation of cleanrooms

We ensure that your cleanroom is compliant with applicable standards so as not to risk affecting the quality or characteristics of a product. Validation includes both technical tests and a review of procedures, documentation and staff flows.

Validation of cleaning

With a structured and transparent validation process, you get a safe basis for your production, with verifiable results. With our validation, we check and ensure that cleaning processes are sufficient to prevent contamination.

Validation of analytical methods

Analytical methods need to be validated to ensure accuracy and reproducibility. Customized validation ensures that methods meet regulatory requirements, pharmacopoeias and internal quality standards.