@Article{M-10486,
AUTHOR = {Raghunathan, Niranjana},
TITLE = {A Cross-Domain Enterprise LIMS Architecture for Organ Bioprinting: Bridging R&D, Process Development, QC, and GMP Manufacturing},
JOURNAL = {Scientific Research Journal of  Biology and Life Science},
VOLUME = {4},
YEAR = {2026},
NUMBER = {1},
ARTICLE-NUMBER = {M-10486},
URL = {https://isrdo.org/journal/SRJBL/currentissue/a-cross-domain-enterprise-lims-architecture-for-organ-bioprinting-bridging-rd-process-development-qc-and-gmp-manufacturing},
ISSN = {2584-0606},
ABSTRACT = {Organ-scale
three-dimensional (3D) bioprinting is poised to transform transplantation
medicine and advanced therapeutics; however, translation from laboratory
innovation to regulated, multi-site manufacturing remains constrained by
fragmentation across research (R&D), process development (PD), quality
control (QC), and GMP production. This paper presents a cross-domain enterprise
systems architecture that positions Laboratory Information Management Systems
(LIMS) as the digital backbone spanning discovery through commercial
manufacturing, establishing a continuous, auditable digital thread for organ
bioprinting. We define quantitative manufacturing and translation metrics
Reproducibility Index (RI), Throughput Scalability Factor (TSF), Protocol
Deviation Rate (PDR), and Documentation Completeness Score (DCS) and a
validation-by-design lifecycle aligned to GAMP5. The framework is grounded in
thirteen years of enterprise-scale LIMS and data-integrity leadership across
pharmaceutical R&D, QC, and manufacturing. This paper follows the SCIRP
structure and proposes a systems engineering framework integrating LIMS into
bioprinting. We argue that organ bioprinting will not become an industrial
discipline without cross-domain informatics governance, and we provide an
immediately actionable blueprint for implementation.},
DOI = {}
}