Gap and Risk Assessments

Gap and risk assessments are commonly used to help improve aspects of your organization, to prepare for an external audit, or to ensure your drug development program is on track. The Kymanox Assessment Team can help you identify the gap between your current state and the desired future state, along with the necessary tasks needed to close all gaps. Kymanox can assist your organization with:

1. Finding and Addressing the Issues – We are experienced in carrying out not only the gap analysis with detailed remediation recommendations, but we have resources available to address or remediate any gaps identified in the assessment. In many cases, we have a template we can provide from our KymanoxWORKS library.

2. Providing a Business Case – If you are in the beginning stages of a project and need to support the business need by developing a Return On Investment (ROI) calculation for proposed improvements, we can assist in providing value-based (e.g., net present value, payback period, incremental rate of return) business cases to get your project off the ground.

3. Functionality Gaps – If you are dissatisfied with a particular system and question whether the capabilities of the system are being used to their full potential, we can help your team identify ways to improve your business process systems or find the best alternative.

A sample of our proven past performance includes:

  • Regulatory Audit Preparation (FDA, EMA, ISO, et al.)
    • FDA Pre-Approval Inspections (PAI)
    • ISO 13485:2016 for Devices
    • Global 3rd Party Supplier Quality (Biologics, Devices, Drugs)
    • ISO 9001:2015
  • CGXP Facility Design (Space, Layouts, Flows, Utilities, Compliance, etc.)
  • Computer System Validation and Part 11 Compliance
    • ERP: SAP, Sage, Microsoft Dynamics, NetSuite
    • BMS/BAS: Honeywell, Rockwell, Siemens, Johnson Controls, Custom PLC/SCADA
    • Cloud-based architectures
    • Document management systems (all types)
    • Data historians
  • USA Sterile Compounding Operations (503A and 503B)
  • Project Management Office (PMO) Best Practice

Our extensive experience in gap analysis allows us to assist your company in a way that fits your process, budget, and schedule. Kymanox can help you manage the full gap analysis process or step in as needed to provide support.


smalllogoblack255x85KymanoxWORKS offers a GXP Regulatory Audit Toolkit. For more information, please view the package at our store.  


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