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Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

Kymanox 22Apr2020 Validation

by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by …

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Annex 11CFR Part11compliant manufacturingcompliant order to cashcompliant supply chaincomputer systems validationdrugelectronic recordselectronic signaturesemaEnterprise SolutionerpfdaguidelinesinstrumentationLife Sciencesmedical devicepatient safetyproduct lifecyclequality management systemregulatory requirementssoftware migrationssoftware upgradessoftware validationTitle 21
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