IDMP Readiness Checklist: A Guide To Preparing For The New ISO Standard

IDMP is on the horizon. After years of waiting, the new ISO standard is set to go into effect in 2023, more than a decade after it was first announced. Life science organizations must act quickly to ensure they are prepared to maintain compliance under the new guidelines, which require more detail than any existing standard.

With IDMP, every aspect of the organization will be affected: from discovery to post-market authorization, all referentials will need to be uniform. Maintaining compliance will require seamless communication across the organization and technology that can facilitate fast and accurate translation from existing internal language to that of the new standard.

It’s imperative that organizations seek a long-term, holistic solution now. While the EU is the first to adopt IDMP, it’s expected that other ISO countries will soon follow, and regulatory bodies will likely enforce IDMP compliance more stringently in the future, seeking uniformity across the life sciences – not just within the Regulatory Affairs team. In fact, the FDA has already communicated its intention to follow suit. Given the impact IDMP will have on entire organizations, it’s critical that technology solutions be implemented now to allow plenty of time to test workflows, data changes, and business impact before compliance becomes mandatory.

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