InnovX Consulting Services
As members of the life sciences community, there are numerous standards that must be understood and followed to maintain compliance. InnovX coaches and guides your team on how to best meet those standards. Whether you need to address enterprise compliance or system-specific compliance, InnovX can help.
Our Core Business Services
Auditing
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Quality System
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SOX Readiness
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Software Validation and Data Integrity
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System Gap Assessment
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Vendor Audit
Typically includes:
Data Integrity Audit Reports, Gap Analysis Reports, IT and Software Validation Documentation, Quality System Audit Findings, SOX Readiness Assessment Results
Commissioning, Qualification & Validation (CQV)
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Computer System Validation (CSV) | Software Quality Assurance (SQA)
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Infrastructure, Laboratory Systems and Equipment Validation
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Validation as a Service (VaaS)
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Commissioning & Decommissioning
Typically includes:
Functional Specifications, Risk Assessment, Traceability Matrix, User Requirements Specification, Validation Master Plan, Validation Plan Report
Policies and Procedures
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Procedural Structure and Roll-Out Strategy
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Quality as a Service (QaaS)
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Quality System Assessment
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SOP Creation
Typically includes:
IT System Procedures, Procedural Implementation Plan, Quality Documents (SOP, Policy, Work Instructions, Forms), Quality Gap Assessment, Remediation Plans
Training
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Compliance Training
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Platform Training
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Training Gap Assessment
Typically includes:
Custom Training Material, Training Gap Assessment, Training Management Procedure, Training Plan
Need Help? Let Us Guide You Towards Hassle-Free Compliance And Support Every Step Of The Way.
Describe your needs and a member of our team will be in touch you.