BPAQuality365
BPAQuality365, a QMS software, can be used in your secure Microsoft 365 cloud. It leverages tools used daily by collaborators and does not require you to change your user habits. It is modern, compatible with all devices, adaptable to your specific needs, and powered through innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, process and process maps, incident, change, risk, FMEA, SWOT, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app integrates with Teams discussions and users can ask the QMS while chatting in Teams and share QMS card with their colleagues. You can go further to achieve your Quality 4.0 goals by combining powerful AI features with best-in-class workflow automation and business intelligence. BPA's Microsoft Preferred status allows you to customize your QMS to meet your needs, share knowledge with your power users, and learn about M365 technologies.
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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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