Factors Contributing to Data Management Struggles

For both clients and providers, a multitude of factors complicate lab data management.

Diverse Stakeholders

Data are used by many different stakeholders across R&D, development, chemistry/manufacturing/controls (CMC), IT, production/manufacturing, QA/ QC, clinical/bioanalysis, process analysts, corporate management, environmental/health/safety, and procurement.

Varied Technology

While a large portion of respondents used electronic laboratory notebooks, around a quarter also relied on a scientific data management system (SDMS) or a lab information management system (LIMS).

Key Regulations

While Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) topped the list of regulatory concerns, many respondents also cited clinical and ISO regulations as a priority.

Data Strategy

Both bio-company respondents and providers said their current lab-data management strategy primarily focused on capturing and driving results, as well as on process optimization. FAIR data principles were also a concern.