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The safety package

Validation guarantees that all manufacturing processes at WILD are tested in accordance with the required regulations and carried out in a secured manner. This helps to reduce time to market and improves the stability of a new or existing product.

In order to be able to manufacture a high-tech product in reproducible quality, one needs a system of stable production processes. At WILD, these processes are regularly reviewed as part of the validation system. “In simple terms, the quality management department tells us what needs to be done so that each production step is carried out in a manner that secures the required quality on a continuous basis. Validation ensures that all processes meet the high requirements and remain stable in the long run. This also constitutes a kind of self-control that minimises risk and provides certainty in daily work”, explains Emmerich Kriegl, Head of Quality Management WILD GmbH.


Safe process, easy entry to market – validation and its benefits

The cornerstone in achieving process stability lies in a profound risk analysis which is implemented as a process-error possibility and influence analysis (PFMEA). WILD integrates its results into work and test instructions and test reports which constitute the framework for a production process in compliance with the specifications. Especially in medical technology, this ensures regulatory certainty during audits and inspections, which many customers depend on. These include a leading international high-tech company which develops and produces diagnostic devices for ophthalmology and sells these to, among others, the American market. WILD manufactures a special scanning laser imaging module for this long-standing customer which is used in the entire product family and must be manufactured in compliance with GMP. “The equipment qualification and validation system implemented at WILD guarantees stable production and quality assurance processes as well as regulatory safety for our customers”, says Emmerich Kriegl. The systems partner thus makes an important contribution to allowing these products to be marketed in the American market without any problems.