Product/Service

Compliance Support - Validation Toolkit, Validation Documentation, Validation Templates

Source: Siemens Industry, Inc.
Life Sciences manufacturers need to fulfill many requirements on their way through the often impenetrable jungle of constantly changing GMP regulations. Increased time to market for new products and continuously increasing cost and pricing pressures make it difficult to succeed. New initiatives such as PAT (Process Analytical Technology) and a Risk-based Approach place high demands on the qualification and validation of their processes, forcing manufacturers to rethink their current approach.

How can Siemens help? Siemens can be your guide in matters of validation. With our indepth knowledge of GMP and FDA requirements, pharmaceutical technology and automation processes, Siemens assist our customers in finding the approach that best fits their manufacturing needs.

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•Flyer: Validation Solutions From Siemens

Quality from the word go
We understand the high standard of requirements for pharmaceutical manufacturing and because of this our products, systems and equipment have been developed to fulfill the most stringent quality demands.

Our quality management systems ensure quality "From the word go", i.e. throughout the entire product life cycle. Quality standards such as ISO 9001 or ISO 14001 are an integral part of the process at all Siemens production sites.

Siemens customers expect a level of quality that either meets or exceeds their own standards. Siemens lives by these quality standards not only to make sure that Siemens products adhere to our customer's strict standards of quality but also guarantees a superior technological offering.

Anyone who consistently abides by such principles "automatically" acts responsibly in regard to quality. Because of this our customers know that Siemens will provide the highest level of quality through good process performance and conformity to the law – in other words, a high degree of customer satisfaction.

Siemens Validation Toolset
The Siemens Validation Toolset is a comprehensive documented methodology to support validation of computerized systems and GMP compliance.

By applying Siemens Validation Toolset to your manufacturing process, the validation of a Siemens system is often significantly reduced with respect to time, cost, and risk versus traditional validation methodologies.

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•Flyer: Validation Solutions From Siemens