Resource Guides

	Code of Federal Regulation Handbooks Our CFR handbook guides contain the minimum current Good Manufacturing Practices (cGMPs) for life science professionals, and help provide a framework for your quality management system. (Select a handbook) 21 CFR 820 – Quality System Regulations 21 CFR 210-211 – Drug GMPs 21 CFR 111 – Dietary Supplements 21 CFR 606 – Blood Industry
	ICH Handbook Our ICH handbook guides help provide a framework for the production, risk and quality systems management of pharmaceutical products. (Select a handbook) ICH Q9 – Risk Management ICH Q10 – Quality Systems
	QSIT Manual Our QSIT manual provides guidance on the inspectional process used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations. (Select a manual) QSIT for Medical Device
	Compliance Map The PathWise Compliance Map is an electronic, Excel-based tool which provides in depth alignment of all worldwide quality system regulations. It contains an easy-to-access view of the regulation scope, terms and definitions, document control, general requirements, management responsibilities and commitment and applicable quality policies. Countries outlined include the United States, Europe, Canada and Japan. (Select a product) Compliance Map

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Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.

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