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Translational Medicine

Translating novel products from bench to bedside is a unique challenge. Translational products can be a hybrid of novel and conventional processes, with evolving requirements as you refine and elaborate the manufacturing process. STEMSOFT batch record software is highly configurable, with an implementation methodology that allows you to focus on novel processes, adapting your documentation strategy to match your level of manufacturing and regulatory maturity.

STEMSOFT commercial-off-the-shelf batch record and manufacturing software is configurable and workflow-driven. Integrated support for barcoding, instrument integration, in-process calculations, and business intelligence ensure that you have accurate and complete records, and the ability to mine them for insights in real time. STEMSOFT products are continuously updated in line with the ever-changing regulatory and accreditation landscape affecting the cellular therapy community.

STEMSOFT eBPR software helps you reduce duplicate data entry, slips, lapses, and mistakes while also making it easier to maintain complete and accurate manufacturing records. Our software can help you maintain your FACT/JACIE and AABB accreditation; ensure compliance with cGMP, cGTP, GDPR, HIPAA, 21CFR Part 11, Annex 11 and ISBT; and generate the data you need to ensure that your team consistently delivers standard of care and advanced medicinal products.

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Software Solutions to Support Your Entire Translational Medicine Workflow