STEMSOFT FOR

Biotechnology

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

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.

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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