gxp in the cloud is a good practice. here's why
TRANSCRIPT
GxP in the Cloud is a good practice. Here’s why.
What Does The Law Require?
Pharmaceutical and Life Sciences companies are required by law to meet Validation and Good Practice Standards (GxP) when building systems for:
Clinical Trials
Quality Assurance
Regulatory Information Management
Manufacturing
Electronic Health Records
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Good Practice Standards
What Is Validation?
The FDA defines validation, pertaining to electronic systems, as “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular
requirements implemented through software can be consistently fulfilled.”
How Is Validation Achieved?
Validation is achieved through GxP:
Verification and testing to ensure identified requirements are met by the software
Planning the system requirements in cooperation with subject matter experts
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Traceability
Mapping the requirements to the different
elements of the implemented system
Configuration Management
System is secured to the correct participants
System is consistently available
Data is guarded against unauthorized
access and changes
Data is recoverable in the event of a disaster
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Past ProblemsOld systems do not:
Meet your current needs
Connect to your enterprise systems
Support mobile capabilities
Connect to other cloud based systems
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Why In The Cloud?
Modern applications in the Cloud allow for cutting-edge systems to meet your organization’s needs today and into
the foreseeable future without the burden of validation from scratch.
What Will The Cloud Do?
Installation qualification requirements
Performance qualification requirements
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An application in the Cloud will provide:
Result?
You can concentrate on the operational qualifications of the business solution itself.
Appian’s Cloud-Based GxP Solutions
Availability
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Appian’s cloud-based GxP solutions are solidly structured on the Amazon Web Services (AWS) architecture so you can have confidence in:
Disaster recoverySecurityPerformance
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