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Process Architecture and Systems Implementation
Building ISO and cGMP systems using process mapping tools and a systems approach to management. Your process owners will evolve and eventually run the Quality Management System.
Our goal is not to live at your company but to enable your company to succeed on its own.
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Training
Curricula tailored to your requirements, with an emphasis on the Medical Device, Pharmaceutical, BioTechnology,
and Information Management industries, as well as their Suppliers
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Service
Offering three levels of service and deliverables in all aspects of work contracted, performed, and administered. These levels will have a scope starting with basic compliance needs to full systems architecture.
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Technical Writing
Will design manuals and process maps to meet your regulatory requirements as well as the practical aspects of your business needs.
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Regulatory Damage Control
We become your representative with the FDA and ISO registrars. MidWest Process Innovation takes negative inspection results and turns them around for compliance and a continued positive relationship with regulatory agencies.
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Package Design
Regulatory concerns loom particularly large over labeling and packaging. Through our partnership with
leading design and branding firm
TippingSprung, LLC, we offer a full range of package-design and label-process services, ranging from designing packaging that meets international regulatory requirements and is user-friendly, to sophisticated solutions that integrate XML and other document standards.
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Translation/Globalization Services
While many of our clients are focused on regulatory compliance at home, the issues are equally vital when the product is sold in international markets, often where you have less control. We offer a full complement of regulatory-compliant translation and multilingual solutions to ensure that your labeling and IFUs are translated accurately, idiomatically, and rapidly.
If you have not already implemented an ISO or GMP-compliant
translation process, give us a call to discuss what your
exposure might be. |