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“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

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Zero Defect Packaging

Zero Defect Compliance Labeling“Failure in labeling is not an option. There are no short cuts in achieving zero defects.”

Ramin Khoshatefeh
Chairperson and CEO, enLabel Global Services
addressing executives in a Medical Device Executive Roundtable Briefing

Companies must beware of compliance solutions that are short of optimal. Low level systems that lack detail, low cost software and systems that are put together without supporting processes and methodology cannot provide a consistent long term solution. Many so called "compliance systems" do not offer the detailed features that are necessary to achieve the level of quality required in the implementation of a world class automatic identification system. A world class system will offer reliability, integrity, security and safety with zero defects.

Zero defect implementation and compliance are processes, not events, and must be treated as such. System components must be designed for adherence to compliance standards and should not be an afterthought. Often systems that are retrofitted to have compliance capabilities lack the infrastructure, security and workflow and do not meet closed system requirements. These systems are vulnerable to penetration by intruders and hackers. Their validity will not withstand litigation nor will they pass proof of performance for reliability and security.

enLabel Global Services methodologies, processes and technologies are based on zero defect principles which are time tested and universally accepted. Conforming to the principles of zero defect consistently assures that we are successful in the creation, implementation and maintenance of global systems 100 % of the time.

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

 

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