DataLyzer Qualis
DataLyzer SPC Qualis (a fully-integrated webbased statistical process control (SPC), software) simplifies the task of real-time data gathering, charting and analysis in any manufacturing operation. It provides powerful analysis, reports and dashboards, supports efficient data collection from any source, and delivers programmable shopfloor screens. The solution provides instant operator feedback, real time data entry, and audit traceability to IATF16949, VDA and RM13006 compliance.
It has powerful features to be integrated with MES or ERP systems.
DataLyzer Qualis integrates with DataLyzer Gage management for calibration and MSA and with DataLyzer FMEA software offering a complete APQP suite.
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SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
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Total Lean Management (TLM) Software
TLM QMS Software is a powerful and robust quality, risk and material management software (QMS) which is validated and 21 CFR Part 11 compliant. TLM is a cutting-edge, all-in-one quality management system that can be customized to integrate with online CRM software, QuickBooks or ERP databases.
Total Lean Management (TLM) QMS Software is specifically intended to be a low cost, highly integrated, flexible and continuously improving landscape to which specialty systems can be added where needed to create the digital business landscape that enables work flows the way your company needs them to work.
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SBS Quality Management Software Suite
The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance:
SBS Quality Database
- CAPA / 8D corrective and preventive actions (CAR) with root cause analysis
- Nonconformance management
- Risk analysis including FMEA, SWOT, interested party risk register
- Internal, customer, and third-party audit management
- Environmental Health and Safety (EHS / HSE) management
SBS Ground Control
- Employee training management (LMS)
- Self-Paced training
- Document control
SBS Asset Tracking Database
- Calibrated equipment control
- Preventive maintenance
- Asset inventory management
SBS Inspection Database
- Record incoming material, in process, and final product inspection data
- Generate real time SPC charts
- Inspection plans and Control Plans
- Archive data for further statistical analysis
SBS Vendor Management
- Maintain an approved vendor list or AVL
- Develop vendor / supplier qualification plans
- Maintain vendor / supplier qualification history
Modules may be purchased separately or in any combination.
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