“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”
Institute of Medicine of the National Academies

Methodology

Our success in the resolution of tough compliance problems and the implementation of global systems with significant ROI can be attributed to our proprietary solution delivery methodology known as 7 C's. Packaging Management Methodology

enLabel has developed a unique Integrated Packaging Management methodology referred to as the 7C's ™, which maximizes efficiency, quality and value for its clients. A collaborative process, 7Cs ensures that everyone involved in the IPM solution understands the packaging issues that have been identified, how they will be addressed and the process through which they will achieve ultimate success.

7Cs incorporates the latest techniques and processes proven through fieldwork, research, testing, analysis, and the study of industry's best practices. enLabel's executive leadership team, advisory board and practice champions have all contributed to this methodology with practical solutions derived from their decades of real-world experience. Their working knowledge of business processes, financial management and IT integration has assured that the 7Cs methodology meets the needs of enLabel's diverse clientele.

Principles

	Planning and Outlining the Scope
	Strategies, Objectives and Tactics
	Delivery and Execution
	Measurement and Accountability
	Alignment and Adjustment

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

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