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Bringing a commercial cell therapy or biological product to market is challenging and requires specialized tools. STEMSOFT electronic batch record software can scale as you do, adapting your documentation strategy to match your level of manufacturing and regulatory maturity while also managing the complexity that results from using a unique, uncharacterizable, and irreplaceable biological product as your raw material.

STEMSOFT commercial-off-the-shelf batch record and manufacturing software was designed specifically for cell therapy and biological product manufacturing. It is configurable and workflow-driven, designed to manage highly variable and responsive manufacturing plans. 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 Biotechnology Workflow