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I am very pleased to welcome you to the SMB Validation & Compliance Services Web Site. We have designed it as a source of information in the hope that it will be of assistance to you. Please feel free to use this resource as you need it.

Through this site, we would like to share with you our experience and our vision of equipment qualification. Our fundamental belief is that “Validation is a regulatory requirement within a business environment, not a science.” We understand that, while equipment qualification is an important and necessary requirement, the reason companies buy equipment is to run production, not to create large amounts of documentation. We prepare and execute concise and practical qualification protocols.

For the Pharmaceutical or the Medical Device manufacturer, our aim is to get your equipment into production promptly while systematically ensuring that all regulatory requirements are fulfilled. We support your acquisition of the equipment by reducing the delay before it can go into production thereby quickly generating the returns that justified its purchase.

For the equipment designer and supplier, our goal is to help you understand your customers’ needs and regulatory requirements, and to manage those needs and requirements for you. We make the transition from your factory to your customer’s plant as smooth and efficient as possible.

For both sets of customers, we are the link that ensures that the equipment is installed properly, operates as designed and performs to expectations. We provide “timely and painless equipment qualification” and we bring an independent perspective to reinforce the integrity of the validation process.

Over the last several years, we have worked all over the world with numerous equipment designers and builders as well as with large number of Pharmaceuticals and Medical Device manufacturers. Our successful track record is one that we are proud of.

We want you to know that we welcome your suggestions and comments. Please share your ideas with us on how we can improve the resources within our site. You can communicate with me at sales@smbvalidation.com.

At SMB, we strive to provide the right amount of validation. Our product is Knowledge. We would like to share it with you.

Claude Swift

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