Helping you reduce risk whilst maintaining compliance

SMARTRISK is a next generation risk assessment tool developed to assist companies with the correct implementation of the EU Guidelines of 19 March 2015 on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.

The intent of the tool is to assist MA Holders with the correct implementation and execution of a Formal Risk Assessment that is in compliance with the intent and purpose outlined in the EU guidance document.

This is the first Risk Assessment Tool (or module) that has been developed as part of SMARTRISK. Further tools have been developed and will be added as future available modules on the SMARTRISK platform.


  • Compliance: Ensures compliance awareness with the EU Guidance through incorporation of the guidelines into the structure of the Risk Assessment tool
  • Guidance: Ensures that the MAH performing the Excipient Risk Assessment assesses the GMP controls that they need for the excipient and then performs a gap analysis against their current or proposed suppliers
  • Security: Provides data security for the Excipient Risk Assessment through audit trail, controlled access and revision control
  • Risk Mitigation: Identifies level of risk  which enables the MAH to take action to control the level of risk where required to ensure mitigation of the risk and GMP compliance of their excipients
  • Objective Assessment: Standardizes the scoring applied to each parameter using clear and concise definitions to minimize subjective scoring, reducing bias and encouraging an objective assessment of risk
  • Reporting: Provides reporting by excipient or a summary of all excipients in the risk assessment


  • User Friendly:  Interfaces with the company’s ERP system to upload existing excipients and formulations. It is user-friendly and requires no additional knowledge about IT systems
  • Stability:  Built on Microsoft’s Azure cloud platform, there is no dependency on third-party software thus reducing the risk of error with Microsoft’s high service level agreements (99.9% uptime guarantee)
  • Availability – Securely accessible from any internet enabled location / device without the need for any specific software
  • Usability – Redeveloped interface focused on performance and optimized user journeys, reducing effort required to enter, maintain and assess data, with all information about excipients and formulations captured in one database
  • Control – improved audit trail functionality and visibility

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