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cGMP Manufacturing

Manufacturing advanced therapy medicinal products requires detailed, complete, and accurate records. STEMSOFT batch record software is configurable and workflow driven, allowing you to focus on producing perfect products, not perfect documents.

Features like barcoding, instrument integration, in-process calculations, and heterogeneous system integration reduce data entry, transcription errors, slips, lapses, and mistakes without sacrificing accuracy or completeness. The STEMSOFT implementation methodology helps your team focus on the parts of your processes that are unique, while adopting standard approaches to those that are not. All to reduce cost and time-to-go-live.

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 cGMP Manufacturing Workflow