The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance:
1) 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
2) SBS Ground Control
- Employee training management (LMS)
- Self-Paced training
- Change control
- Document control
3) SBS Asset Tracking Database
- Calibrated equipment control
- Preventive maintenance
- Asset inventory management
4) 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
5) 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.
On-premise and cloud-based options are available.
Free demos are available for download or contact us for a cloud-based demo.
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Intelex delivers a unified software system for overseeing Environmental, Health, Safety, and Quality (EHSQ) initiatives. Its expandable platform is crafted to consolidate, oversee, and scrutinize EHS and Quality data comprehensively. The solution works on any device to meet the realities of your workplace.
With Intelex, your organization can:
Elevate your EHSQ program outcomes by supervising workflows for superior performance and command.
Discern patterns and propensities through goal-setting to deepen understanding and improve decision-making in your EHSQ program.
Diminish occurrences and cut down on administrative tasks by efficiently supervising, managing, refining, and extracting insights from your safety data via our intuitive safety software.
Simplify the management and reporting of air, water, and waste emissions, and oversee environmental outputs to fulfill sustainability objectives.
Foster ongoing improvements in quality by seamlessly logging and monitoring all instances of nonconformity within a unified, web-based system. Investigate trends across various departments, sites, or locations.
Intelex can help you manage compliance with international standards and regulations such as: OSHA, WCB, ISO 45001, EPA, ISO
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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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DataLyzer FMEA
FMEA is critical in avoiding risk and minimizing quality cost. DataLyzer FMEA offers DFMEA, Process Flow, PFMEA and Control Plan and they are all linkedin avoiding time to synchronize the steps. From Control Plan the SPC setup can be automatically created.
Many features are available like reference or Foundation FMEAs, different criteria or classification sets, full authorization, Document and issuing control, Action management, Ballooning import, Automatic translation, Reporting, ITAR configuration etc etc
DataLyzer FMEA saves a lot of engineering time avoiding repetitive work.
DataLyzer FMEA closely follows the methodology defined in VDA AIAG and RM13004. DataLyzer FMEA can link to DataLyzer SPC software.
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