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Points to Consider When Validating Computer Systems for CGMP Processes

Kymanox 24Apr2020 New, Validation

Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require …

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cgmpCGxPcomputer softwareComputer System Validationcsvdata integrityelectronic dataelectronic recordsgampGood Automated Manufacturing PracticesLife ScienceLife Sciencespatient safetyQuality Risk Managementrisk assessmentrisk managementsoftwaresoftware interfacesoftware systemssoftware validationsopStandard Operating Procedures

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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