SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform 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, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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SBS Quality Management Software Suite
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server.
Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user.
The SBS QMS Suite of modules:
SBS Quality Database
- CAPA / 8D with root cause analysis
- Nonconformance management
- Risk analysis (FMEA, SWOT, risk register)
- Audit management
SBS Ground Control
- Employee training management (LMS)
- Document control
SBS Asset Tracking Database
- Calibrated equipment
- Preventive maintenance
SBS Inspection Database
- Data collection / SPC
- Control Plans
SBS Vendor Management
- Approved vendor list / AVL
- Supplier qualification plans
Great product for efficient and affordable QMS Compliance.
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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[FP]-LIMS Software
The [FP]-LIMS modules are based on a powerful SQL database solution. These allow a quick query and processing of data. We guarantee maximum user-friendliness! Our job server is a central element for the automation of functions, which executes time- and event-controlled tasks. Like, to automatically monitor limit values and the associated alarm message (e-mail, message on the monitor, etc.) when they are exceeded. Using modern LIMS software and modules such as analysis management, inspection planning, workflow management, or ERP, you can design your quality management in the best way. This makes your production processes more efficient.
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