GxP Systems Implementation Services

• Digital Transformation Strategy.
• Digital Transformation Tactical Plan.
• Compliance Assessment.
• Data Integrity Assessment and Remediation.
• Audit Readiness Assessment 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 assessment.
• GxP systems complexity assessments.
• SOPs.
• Training Plan.
• Training Materials and many other. LIMS validation services.

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

• Product Development Support.

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.