Education is a must for a successful introduction of innovative software solutions in a business process: end-users must be able to understand the new technology opportunities, to define appropriate requirements and validation strategy, to maintain the system governance and compliance status during the entire software lifecycle, from go-live up to retirement.
K2C training courses include but are not limited to:
Software Solutions and Pharmaceutical Quality System
Software and GxP regulations: applicable regulations and best practices
Risk Analysis and Risk Management applied to Computerized Systems: methodologies and applications
21 CFR part 11: interpretation, application and remediation plans
Software Compliance and required Standard Operating Procedures in a GxP environment
IT Security in a GxP environment
IT Project Management: methodologies and tools
IT Supplier Selection and Qualification
Computerized Systems Validation in a specific regulatory environment (GMP, GCP, GLP, GCLP etc.)
Development and Validation of Electronic Content and Document Management Systems
Microsoft SharePoint for beginners
Microsoft SharePoint for system administrators
Contact us for more information.