Digital CMC Regulatory Lifecycle (DCRL) Workflow

Providing a structured, end-to-end pathway for developing, assessing and deploying digital predictive tools in pharmaceutical CMC.

Digital CMC CERSI Home Page

DCRL Workflow

Developed by the Digital CMC CERSI, it directly supports the CERSI mission to enable innovation in regulatory science while maintaining product quality, patient safety and global regulatory confidence.

The workflow translates high-level regulatory principles into a practical, stepwise approach that can be applied consistently by industry, regulators and researchers across the product lifecycle.

Digital CMC Regulatory Lifecycle (DCRL) Workflow

The 10 stages of the DCRL Workflow

  • Clearly identify the scientific or operational question the digital tool is intended to address.

  • Specify how and where the tool will be used (e.g. development, manufacturing, regulatory submission) and its impact on decision-making.

  • Determine the most appropriate modelling approach (e.g. mechanistic, data-driven, hybrid) based on the question and available data.

  • Assess the potential impact of model errors on product quality, patient safety and regulatory decisions.

  • Define the data strategy, including sources, quality requirements, and experimental or operational data generation.

    Need to add more detail for this section.‍

  • Develop the model and begin assessing its scientific validity and performance against the intended use.

  • Evaluate whether the model is sufficiently reliable and robust for its defined context of use.

  • Understand how model uncertainty could propagate into manufacturing control or regulatory decisions.

  • Prepare clear, transparent documentation to support regulatory submission, inspection, or internal governance.

  • Maintain and monitor the model over time, including updates, revalidation, and ongoing performance oversight.

Evidence base and sources

The DCRL workflow is grounded in a broad and evolving evidence base. It integrates:

  • Global regulatory guidance (e.g. ICH quality guidelines, FDA, EMA, MHRA)

  • International standards (e.g. ASME, ISO and related model credibility frameworks)

  • Scientific literature and peer-reviewed best practice

  • Industry white papers and cross-sector experience

By consolidating these sources into a single, coherent workflow, the DCRL provides a harmonised and practical approach that reduces ambiguity, aligns expectations across regions, and supports consistent regulatory decision-making.

For CERSI, the DCRL workflow is a key mechanism to bridge innovation and regulation—enabling digital and AI tools to be adopted in a way that is predictable, proportionate, and globally aligned. It helps ensure that advances in digital CMC translate into real-world benefits: faster development, more resilient supply chains, and continued assurance of safe, high-quality medicines.