Qualcy QMS
Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.
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Calibration Control
Use Calibration Control (CC) for Calibration, Maintenance, or general Asset Management. Quickly and visually track equipment that requires Calibration or Maintenance using customizable highlighted grids, auto emails, or reports. Maintain histories with audit trails relating to equipment traceability, people, companies, related documents, attachments, certificates, & more.
Automate Calibration Control with custom or default barcode labels scanned by time-saver data entry dialogs to increase speed and traceability. Use the Report Designer for custom reports or modify existing reports.
ISO, FDA, & ANSI quality systems use CC to maintain compliance and effortlessly communicate that compliance to auditors and internal customers. Although CC grew up in a Manufacturing environment, it is also used in other industries like Metrology Services, Health Care, Aviation/Aerospace, Mining, Testing, Maintenance, Designer Engineering, Oil Wells, Distribution, Packaging, and others.
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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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