Qualer
Qualer is a dynamic asset and service management software designed to automate asset maintenance, service, and calibration workflows and enhance collaboration with both internal stakeholders and third-party service providers. Qualer's secure, cloud-based platform allows users to manage their assets from anywhere in the world with a simple internet connection.
Customizable reporting and dashboards help you digitize your workflows and centralize documentation to prepare you for audit. Qualer is 21 CFR Part 11 validated and simplifies audit preparation by minimizing error potential and gaps in compliance strategy.
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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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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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QC-Pro Gage Control
Scheduling gage calibrations or verifications. Maintaining historical records of all activities. Measurement System Analysis (GRR, Stability, Bias, Linearity, Attribute Crosstab). Some of the key elements are record before/after readings across the operating range of the gage. Gage calibration schedule can be based on time interval or gage usage. Link external documents (e.g. calibration certificate) to a calibration record. Calibration procedure - free format steps to calibrate gage. Custom fields that are user defined. Data Security - option to restrict edits to existing calibration records. Audit Trail - maintains history of calibration record content prior to an edit. Reschedule gage calibration due dates that fall on holidays, weekends etc. Flexible report filtering (overdue, date range, gage id, location etc.)
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