ASSET TRACKING KEY FEATURES Control of Calibrated Equipment Recall Report for “Out of Cal” Equipment Preventive Maintenance Schedules Track Unscheduled Maintenance Generate Fix-It-Tickets Control Miscellaneous Assets BENEFITS Build a simple and effective Quality Management System (QMS / eQMS) Efficient and Cost Effective Simple, low cost solution. Saves time and improves efficiency. Reduce risk through proper preventive maintenance Quality Effectiveness Helps control calibrated equipment Easily generate a Calibration Recall report Maintenance Due reports show the status of your equipment with a click of a button. A Vital Tool to ensure ISO 9001:2015 compliance Paperless QMS system Scan and link digital photographs, calibration certificates, or other electronic documents. PRICING STANDARD PRODUCT Single User License: $249 2-User License: $299 3-User License: $349 … Continue reading Asset Tracking Database

  KEY FEATURES   Risk Assessment: Failure Modes and Effects Analysis (FMEA) Implement risk based strategies for ISO 9001:2015, ISO 14971 Identify failure modes for each process or item Identify effects and severity Identify causes and frequency Identify current controls and detection levels Develop multiple actions associated with this failure mode Assign owners and due dates Establish verification and validation criteria Electronic signature for management approval User login: define user passwords and privileges Rich set of reports Track open actions and delinquent due dates ADVANTAGES Build a simple and efficient Quality Management System (QMS) Implement risk based thinking required by ISO 9001:2015 Easy to use Collaborative platform Simple, menu driven user interface Easy to train users Convenient, intuitive forms Can … Continue reading FMEA Database (Failure Modes and Effects Analysis)

KEY FEATURES ISO 9001 compliant software used to establish criteria for selection, evaluation and re-evaluation of suppliers: Develop Vendor qualification plans Record qualification results Maintain your Approved Vendor List (AVL) Establish criteria for selection, evaluation and re-evaluation of suppliers Link electronic files (paperless system) Rich set of reports User login: define user passwords and privileges BENEFITS Build a simple and efficient Quality Management System (QMS): Comply with standard Purchasing requirements of ISO 9001:2015 AS9100 TS 16949 Efficient and cost effective Simple, low cost solution Intuitive design = little training required Saves time and improves efficiency Answers are a click away A vital tool to ensure compliance Paperless system:  Scan and link digital photographs or other electronic documents PRICING Single User … Continue reading Vendor Management Database

KEY FEATURES Real-time Statistical Process Control (SPC) Configure Collect data for parts and/or processes Define limits: valid data, specification, and control Chart Display options Collect and validate data against Control Limits Spec Limits Correlate data to process, part #, serial number or work order Real-time SPC Control Charts – generates warnings for spec / control limit violations Simple reports show summary statistics including Cp, Cpk Export raw data to Excel, Word, etc. Unlimited users, no per user licensing Ideal for Final QC data entry BENEFITS Efficient and cost effective Simple, low cost solution Saves time and improves efficiency Eliminates paper records A vital tool to ensure ISO9001 compliance Implements basic data collection and validation to ensure product compliance Eliminates paper … Continue reading SPC Keeper

KEY FEATURES Document Control Complete document lifecycle management Controls any electronic document including Microsoft office files: Word, Excel, PowerPoint PDF, AutoCAD, SolidWorks Control document releases New documents Revisions to existing documents Obsolete documents Ensure approvals are documented Capture electronic signatures Password entry required Organize electronic documents Organize by Type, Department, and Owner Group related documents for quick reference New releases reset training requirements User login: define user passwords and privileges Simple, effective reports Measure the effectiveness of your document control system Training Management Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for revision controlled documents Manage a Training Schedule Certification Requirements … Continue reading Ground Control

  KEY FEATURES SBS T-Med Database is ISO 13485 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Employee Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for revision controlled documents Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees Electronic signature approvals User login: define user passwords and privileges CFR21 Part 11 compliant BENEFITS Build a simple and effective Quality Management System (QMS / eQMS) Efficient and cost effective software Simple, low cost solution Saves time and improves efficiency Training effectiveness Defines roles and … Continue reading T-Med Database

KEY FEATURES Nonconformance Tracking Escalate a Nonconformance to a Corrective Action   Corrective Actions (CAPA) Safety, Supplier, Internal Audit CARs With Validation and Verification Approvals require electronic signatures Preventive Actions (PA) Audit management Record audit findings Manage Audit Schedules Escalate to a Corrective Action or Preventive Action Meeting management Project management Customer satisfaction surveys CFR21 part 11 compliant security, activity logs, audit trails BENEFITS Complies with requirements of ISO 13485, 21 CFR Part 820, ISO 14971 ISO 9001:2015 AS9100 ISO/TS 16949 Provides a concise, electronic record of historical events, actions, and improvement No paper to get lost Efficiently maintains quality records Internal audits Corrective Action results Preventive Action results Management review or MRB meetings Nonconformances Customer satisfaction surveys Improve product … Continue reading Q-Med Database

  KEY FEATURES SBS Training Database is ISO 9001 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Training Records Define Job Descriptions / Roles and Responsibilities Define Training requirements by position (standard training for each position) by employee (special training for each employee) for the release of controlled documents Certification Requirements Re-Certification Requirements Document revisions trigger training requirements Email Reports directly to affected employees User login: define user passwords and privileges Compare the Training Database to the T-Med Database BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) Efficient and cost effective Simple, low cost solution Saves time and improves efficiency Effective training management Define … Continue reading Training Database

KEY FEATURES Nonconformance Tracking and Analysis Closed loop Corrective Actions with Validation and Verification (CAPA) Audit Management Risk Management (FMEA and SWOT Analysis) Continual Improvement Projects Preventive Actions Meeting Manager Customer Satisfaction Surveys Rich set of reports and analysis tools for each module BENEFITS Build a simple and efficient Quality Management System (QMS / eQMS) Customer satisfaction Quickly and effectively respond to customer complaints Rebuild customer confidence when things go wrong Monitor Customer Perceptions and take action to improve Efficient and cost effective Simple, low cost solution Saves time and improves efficiency Answers are a click away Quality effectiveness Analyze graphs, charts, and reports on demand Report corrective and preventive action (CAPA) performance metrics List open CAPA with pending actions, … Continue reading Quality Database