Qualis DMS
Qualis document management system ensures secure documentation with controlled distribution to end-users. It provides workflow-based document approval with revision control. End users have the latest approved version of any document reducing the risk of obsolete documentation. The activity workflow can be configured with Roles as per needs. Multiple workflows can be configured to associate with the respective document type. Reduce paper and storage space, secured storage and recovery. Distribution of approved documentation, reduced risk of obsolete copies. Improved regulatory compliance, controlled access with ease of search. All metadata is stored in a central database. Database agnostic (supports MS SQL, Oracle, Postgre SQL). Overall organization-level document management and controlled distribution solution. Qualis DMS is a single platform for integrated document management and control.
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Assai
Assai's DMS stores all your documents, drawings, correspondence, emails, contracts, and purchase orders in a central, easily searchable repository. You control access, and always have the latest versions available to your team. Search functions let you quickly find what you need using metadata or content. Our Document Control system streamlines workflows, with easy setup and maintenance, user inboxes, automatic assignments, and flowchart tracking. We offer Enterprise Content Management that enable complex projects and operations. Get a grip on your projects, assets, documents and data with our Common Data Environment.
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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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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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