Electronic Batch Process Records for Cell Therapy
Backed by nearly 30 years of experience in supplying software solutions to the cellular therapy laboratory market, STEMSOFT LAB provides you with a configurable, workflow-driven, commercial-off-the-shelf electronic batch process record that supports barcoding, instrument integration and in-process calculations. Reduce redundant data entry, slips, lapses, and mistakes with STEMSOFT LAB making it easier to maintain complete and accurate manufacturing records. STEMSOFT LAB gives you the insights you need to ensure your team consistently delivers the products your patients need.
STEMSOFT LAB will 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.
Features & Capabilities
Complete Product Tracking
STEMSOFT LAB provides the flexibility you need to document your full product lifecycle and the various unique relationships attributed throughout. Key features include:
- Support to document and label every product regardless of clinical stage
- Automated chain of custody for every aliquot and sample
- Intuitive data capture with support for attachments
- Storage and freezer tracking making it easy for you to store or retrieve products without compromising integrity
- Integrated lot-to-lot traceability complete with:
- Consumable, supply, and reagent lifecycle management
- Equipment lifecycle management
- Barcode scanning
- Automated calculations
- Secondary sign offs and electronic product release
Data Insights, Analysis and Reporting
STEMSOFT LAB provides the flexibility you need to analyze all of the data you care about. Perform ad-hoc queries on the fly, create automated reports and dashboards to gain more insight into your program including key quality indicators, storage inventory assessments, recall reports, and more. Key features include:
- Custom dashboards
- Custom reporting
- Data analysis
- Interactive data visualizations
Ensure Quality and Regulatory Compliance
STEMSOFT monitors all relevant regulatory and accreditation frameworks so we can equip you with the tools you need to comply with HIPAA, FACT/JACIE, AABB, GxP, 21 CFR Part 11 electronic signatures and more. Key features include:
- Accreditation tools
- Audit trails
- Automated software testing
- Electronic signatures
- Example SOPs
- Forensic audit logs
- Regulatory assistance
- Validation education
- Vendor IQ and OQ validation
- Vendor performed installation
Data Integrity and Integration
Reduce errors and ensure accuracy with integrated tools to import and manage large volumes of data in a live database that does not require distribution of personal health information (PHI) outside of your facility. STEMSOFT LAB features:
- Custom Integration
- EMR Integration
- FHIR Integration
- LIS Integration
- Instrument Integration
Enhanced Security and Quality Settings
Data security is increased with centralized installations directly on your servers or private cloud, full in-system audit trails, LDAP integration and more. Key features include:
- Active Directory integration
- On premise or cloud deployment
- User management
- Role-based permissions
- Forensic audit logs
- On-Screen audit trails
- 21 CFR Part 11 electronic signatures
Convenient Web-based Access
Work how you want, and where you want with the ability to access STEMSOFT LAB from any tablet or computer at your facility. STEMSOFT LAB:
- Requires no software to install on user devices
- Is tablet-ready
- Supports unlimited concurrent users
- Offers on premise or local cloud deployment with a vendor performed installation
Ongoing Training and Support
STEMSOFT offers remote and on-site customized training sessions for both new and experienced users to ease implementation and provide support for your evolving needs. Offerings include:
- Access to in-house experts
- Access to our Support Portal resources
- Complementary product upgrades
- Complementary technical support
- Predictable and proven training program
- Validation education
Optional and Extended Features
Extend your software functionality to meet your needs. STEMSOFT offers additional capabilities that can be easily installed to support the growth of your clinic.
EMR Interface
The STEMSOFT standardized HL7 v2 ADT interface instantly receives demographic and admission data from your existing hospital system into STEMSOFT to help save you time and increase the integrity of your data.
Data Import Toolkit
The STEMSOFT Data Import Toolkit is a command-line tool that supports bulk import of large volumes of legacy data and/or data collected outside of STEMSOFT into your STEMSOFT system. This toolkit can import data into a live database and does not require distribution of PHI outside of your facility.
FHIR
The STEMSOFT FHIR® interface shares relevant, released product information from STEMSOFT LAB to your STEMSOFT CLINIC users using Fast Healthcare Interoperability Resources, a modern, secure, and standards-compliant technology. This level of integration saves you time and increases the integrity of your data.
FHIR® is the registered trademark of Health Level Seven International and the use does not constitute endorsement by HL7.
LIS Interface
The STEMSOFT standardized HL7 v2 ORU interface instantly receives lab test and other observation data from your existing hospital systems into STEMSOFT to help save you time and increase the integrity of your data.
Instrument Integration
Connect your automated devices into STEMSOFT to help save you time and increase the integrity of your data.
STEMSOFT LAB
Get Started Today
Track all of your unique operational and manufacturing details in one location with STEMSOFT LAB and receive ongoing support from our expert team.
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.
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.