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Monique Klein - Compliance through Automation

April 04, 2013 by

Monique Klein, COO – Compliance Through Automation

Having spent several years within the Fortune 500 Life Science environment, I understand the very real cost implications of non-compliance.

For example, since 2009, the FDA has been strengthening key policies within the medical device industry. This has resulted in a 100% increase in Warning Letters issued by the FDA within this industry since 2010 alone.

In addition, the number of FDA regulated product recalls has more than doubled over the last five years in the medical device industry, with 4,266 products recalled in 2006, compared to 9,288 in 2011.

A proportion of product recalls are due to weakness in manufacturing standards or control procedures.

Of course, we know that manufacturing standards are directly linked to product quality. But the combination of automation and compliance are the drivers of standards and as such, key to conformance.

Compliance itself carries a cost. But working with automation partners who are compliance-driven is proven to reduce this cost.

Whether creating a new manufacturing line or scaling up, automation providers can ease the legislative burden by providing machine solutions that adhere to FDA-guidelines and satisfy the rigorous documentary requirements.

Compliance can be found at the heart of Automation GT.

Our system development lifecycle is triggered at the machine concept phase. Rigorous focus on requirements planning, systems & software specifications, test planning and version management & control ensure our machines make FDA compliance simpler.

Supported by cloud-based documentation, redundancy management and traceability control, our extensive standard document packs facilitate a quicker ‘product-time-to-market’ and most importantly, uphold quality standards through the product lifecycle.

To learn more about how compliance can reduce your cost, please contact us.

Monique Klein, Chief Operating Officer

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Links

http://greenleafhealthllc.com/wp-content/uploads/edd/2012/12/FDA-Device-Enforcement-Abbreviated-2013.pdf

http://www.in-pharmatechnologist.com/Regulatory-Safety/Drugmakers-Seeking-Approval-Under-FDASIA-Must-Keep-Manufacturing-In-Mind-FDA