BioPhorum Publishes a Roadmap for QC Sample Test Execution

BioPhorum has published a new paper entitled “Sample test execution: Strategic guidance for advancing digital maturity.”

BioPhorum outlines the background as follows: "Quality control (QC) laboratories are facing increasing product complexity, rising regulatory expectations and greater pressure to work efficiently with high-quality, trusted data. However, not all labs have undergone the same level of digital transformation as manufacturing areas, which can contribute to operational challenges, limit efficiency and slow product release. Labs also continue to navigate barriers to automation, often linked to varying levels of test-execution automation."

The guidance is grounded in the QC Lab of the Future principles and the BioPhorum Digital Plant Maturity Model V3 (DPMM®), using the maturity-model approach to describe what “good” looks like and how labs can progress in a structured way. Following the Executive summary and Introduction, the paper outlines a clear vision for digitally mature sample test execution, with DPMM® Level 3 (Connected plant) as a key milestone and a roadmap toward Level 4 (Predictive plant).

It also highlights industry impact and stakeholder benefits, stressing that it does not prescribe a single solution but instead points to practical enablers to prioritize investments and implement sustainable improvements while maintaining compliance. Separate sections address benefits for biomanufacturers/CMOs and for supply partners, and it dives into implementation topics such as establishing Level 3 and 4 maturity, including data and system harmonization and standardization.

For further information and to download the document, please visit the BioPhorum website.

Go back

NEWSLETTER

Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.