GxP Systems Implementation Services

• Digital Transformation Strategy and Tactical Plans.
• Regulatory Compliance and Data Integrity Assessment.
• Audit Readiness and Remediation

•  Evaluation and Selection.
•  Implementation.
• Project Management.
• Post Implementation Technical Support.
• System Administration.
• Training.

•  Validation Master Plan.
• User Requirements.
• Risk Analysis.
• Validation Strategy.
• Design and Configuration Documents.
• IQ/OQ/PQ. 
• Validation Summary Reports. 
• Project Plan. 
• 21 CFR Part 11 Gap and GxP Complexity assessments.
• SOPs.
• Training Plan.
• Training Materials.
•  LIMS validation services.

• GxP Software Product Management
• Industry Research.
• Strategy Definition.
• Competitive Analysis.
• Win Loss Analysis.
• SDLC.
• Validation.
• Product Development.
• Regulatory Compliance.

• Product Development Support.
• Business / User Requirements
• Sofware Design session
• Validation and UAT
• Go to Market
• Customer Audit readiness
• Validation Package

There will come a time in your business when you need some additional help with ensuring regulatory compliance, audit readiness and. maximizing QA/QC operational excellence,  In addition to long-term compliance support, we can be available for extra hours during new releases and other important events.