STEMSOFT FOR

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

Process

You need a flexible solution to seamlessly document the complete lifecycle for every product, aliquot and sample. STEMSOFT automates full chain of custody for all of your products, includes built-in ISBT 128 and SEC product labels and provides you with the flexibility you need to document the data you care about including interfaced test results, automated calculations, verification activities, scanned documents, full consumable and equipment traceability, clinical outcomes and more.

Store

Being able to identify exactly where your units are located is imperative to your operations. STEMSOFT lets you electronically track and assign all storage locations making it easy for you to store or retrieve products without compromising integrity.

Release

STEMSOFT lets you work how you want, where you want with convenient web-based access from any tablet or computer at your hospital – no software to install or IT to call. Built-in support for 21 CFR Part 11 electronic signatures complete with on-screen audit trails and forensic audit logs makes it easy to document and verify your product release process.

Infuse

Electronically document all of your cell therapy infusions including any product shipment activities, verification tasks, clinical outcomes and more from the convenience of a mobile device.

Analyze

Aggregating data is one thing but mining your data is key. STEMSOFT keeps all your critical data elements in one place and lets you perform ad-hoc queries and generate visualizations on the fly without having to be a report writing expert. Automated and on-demand business intelligence and visualization is also included to provide you with your weekly dashboard, key quality indicators, completed paperwork and more.

Your Software Solution

STEMSOFT LAB

Track all of your unique operational and manufacturing details in one platform, with built-in support for accreditation compliance, processing standardization and data analysis.

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Receive Extended Support with Your STEMSOFT Solution

At STEMSOFT, we know that the proper software solution is only one piece of your cell therapy program. That’s why we’re proud to offer additional services and resources to help you get the most out of your STEMSOFT system.

Receive Extended Support with Your STEMSOFT Solution

Support Portal

As a valued client, you’ll gain access to our users-only Support Portal offering extensive supporting documentation, example Standard Operating Procedures (SOPs), a searchable knowledgebase, video library, newsletters, and more.

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Software Implementation and Ongoing Support

With over 25 years of experience in implementing cellular therapy software solutions, we have developed a structured training approach that will enable your team to easily get started with STEMSOFT today while also providing you with the ongoing training, upgrades, and support you need for the long term.

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