QT9 QMS
QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform.
Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy.
Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability.
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Intellect
Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps.
Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device.
Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.
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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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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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