Equipment Validation

Our equipment validation method ensures equipment compliance: a high degree of assurance that equipment consistently produces a result or a product that meets its predetermined and required specifications.

By validating equipment – like (bio)reactors, autoclaves and packaging machines – companies guarantee the optimum quality, safety and compliance of their products. The validation of equipment consists of various stages, including writing down equipment specifications, carrying out a risk analysis, testing possible risks, documenting test evidence and monitoring.

Equipment validation is a time consuming process. Every significant change to equipment, which may affect the quality of its result, should be validated. Companies face difficulties like a lack of experience or the absence of estimation proper calculation of all the risks of specific equipment. QbD has an extensive range of equipment validation services to guarantee optimal equipment compliance.

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