Gartner Research

Delayed and Confusing IDMP Compliance Requirements Demand Life Science CIOs Pursue a Two-Part Strategy

Published: 21 January 2016

ID: G00289618

Analyst(s): Michael Shanler

Summary

The deadline for IDMP compliance was 1 July 2016, and IDMP compliance is mandatory for MAHs in Europe to operate without fines, but the rollout and standards details are delayed until 2018. Life science IT leaders supporting regulatory compliance can use this research to set strategies.

Table Of Contents
  • Impacts

Analysis

Impacts and Recommendations

  • Unclear regulatory guidance and delays are creating uncertainty for CIOs in establishing data management strategies to support IDMP compliance strategies.
    • Understanding the top-level ISO standards to ensure you know what compliance means is essential.
    • It is also important to understand the data sources and systems involved.
  • The regulatory delays have created a window of opportunity for CIOs to consider a range of value-adding strategies to meet IDMP compliance and align its impact with longer-term needs.
    • Put in the effort to determine true value IDMP compliance.
    • Match your strategic approach to your strategic justifications, which often go well beyond IT, with a focus on MDM.
    • Define the IT, business and supply chain roles upfront, and model what this will look like as a project progresses.
  • Unclear regulatory guidance and delays drive the need for CIOs to implement an agile vendor and resourcing strategy to address uncertainty.
    • Select the right partners. Unfortunately, the vendor-partner pool is small.

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